Trial Outcomes & Findings for Restoring Masticatory Function to Treat Chronic Pain (NCT NCT02144233)

Results Overview

Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

Baseline and 6-months

Results posted on

2020-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Occlusal Adjustmen Therapy Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Overall Study STARTED	39	38
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Restoring Masticatory Function to Treat Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance angle on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.	Total n=77 Participants Total of all reporting groups
Age, Continuous	29 years n=5 Participants	30 years n=7 Participants	30 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Self-reported jaw-pain intensity	7 units on a 0-10 scale n=5 Participants	7 units on a 0-10 scale n=7 Participants	7 units on a 0-10 scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6-months

Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Jaw-pain-Intensity (Affected Side) baseline	7 units on a scale Interval 5.0 to 8.0	7 units on a scale Interval 6.0 to 7.0
Jaw-pain-Intensity (Affected Side) 6-Months	2 units on a scale Interval 0.0 to 3.0	3.5 units on a scale Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 6-months

A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Chewing Side baseline · Right	16 Participants	14 Participants
Chewing Side baseline · Alternate	8 Participants	13 Participants
Chewing Side baseline · Left	15 Participants	11 Participants
Chewing Side 6-Months · Right	6 Participants	6 Participants
Chewing Side 6-Months · Alternate	25 Participants	27 Participants
Chewing Side 6-Months · Left	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, 6-Months

Population: Some self administered questionnaire was not adequately covered by the patient.

Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) baseline	0.89 score on a scale Standard Deviation 0.57	0.81 score on a scale Standard Deviation 0.51
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) 6-Months	0.52 score on a scale Standard Deviation 0.5	0.5 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline, 3- and 6-Months

Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Maximum Unassisted Jaw Opening baseline	41.5 mm Standard Deviation 8.4	43.9 mm Standard Deviation 7.8
Maximum Unassisted Jaw Opening 3-Months	45.66 mm Standard Deviation 7.9	46.73 mm Standard Deviation 7.7
Maximum Unassisted Jaw Opening 6-Months	47.7 mm Standard Deviation 8.4	46.4 mm Standard Deviation 7.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline 3- and 6-Months

Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Headache-intensity baseline	7 score on a scale Interval 5.0 to 8.0	5.75 score on a scale Interval 1.0 to 7.63
Headache-intensity 3-Months	4 score on a scale Interval 1.5 to 6.0	3 score on a scale Interval 0.5 to 6.0
Headache-intensity 6-Months	4 score on a scale Interval 0.0 to 5.0	3 score on a scale Interval 0.0 to 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6-Months

Population: Data from 1 placebo group participant at 6-months not available

Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=37 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Number of Participants With Neuropathic Pain baseline · neuropathic pain	13 Participants	12 Participants
Number of Participants With Neuropathic Pain baseline · without neuropathic symptoms	26 Participants	25 Participants
Number of Participants With Neuropathic Pain at month 6 · neuropathic pain	3 Participants	4 Participants
Number of Participants With Neuropathic Pain at month 6 · without neuropathic symptoms	36 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Handedness preference assessed using Edinburg inventory: Left Right 1. Writing 2. Drawing 3. Throwing 4. Scissors 5. Toothbrush 6. Knife (without fork) 7. Spoon 8. Broom (upper hand) 9. Striking Match (match) 10. Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Handedness Preference right	29 Participants	31 Participants
Handedness Preference left	10 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Note that both sides of each participant was assessed. Recordings from one participant in each group are unavailable.

The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=76 LG Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=74 LG Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Lateral Guidance Angles (LG)	42 degrees Standard Deviation 10.3	40.6 degrees Standard Deviation 11.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Condylar Path Angles right joint	50.5 degrees Standard Deviation 10.7	47.3 degrees Standard Deviation 8.1
Condylar Path Angles left joint	50.1 degrees Standard Deviation 10.5	49.3 degrees Standard Deviation 8.6

OTHER_PRE_SPECIFIED outcome

Timeframe: After therapy, 1-Month, 3-Months, 6-Months

Unexpected Adverse Events (NIH, 2009).

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Adverse Events	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Six months

Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Participant's Awareness With Trial Group Assignment real therapy	26 Participants	21 Participants
Participant's Awareness With Trial Group Assignment I don't' know	12 Participants	14 Participants
Participant's Awareness With Trial Group Assignment placebo therapy	1 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6-Months

Population: Data from one participant from each group was lost from baseline, and 2 from the Occlusal adjustment group and 5 from the placebo group at 6-months.

Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=37 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=33 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Credibility (of Participants) baseline	8 units on a scale Standard Deviation 1.8	8.3 units on a scale Standard Deviation 1.3
Credibility (of Participants) 6-Months	8 units on a scale Standard Deviation 1.9	7.6 units on a scale Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Level of education

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Sociodemography Higher	21 Participants	26 Participants
Sociodemography Secondary	12 Participants	9 Participants
Sociodemography No qualifications	6 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-Months

Population: Data from two participants in placebo group that underwent randomization were not available.

Patient impression outcome will be reported as Improved Vs. no change.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=39 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=36 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Patient Impression (Improvement) Improved	37 Participants	25 Participants
Patient Impression (Improvement) No change	2 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; 6-Months

Population: Data from two occlusal adjustment and six placebo group participants were not available.

In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify.

Outcome measures

Outcome measures
Measure	Occlusal Adjustmen Therapy n=37 Participants Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=32 Participants Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Pain Interference on Daily Activity baseline	5.2 units on a scale Standard Deviation 2.6	4.5 units on a scale Standard Deviation 2.9
Pain Interference on Daily Activity 6-Months	3.1 units on a scale Standard Deviation 2.6	2 units on a scale Standard Deviation 3.2

Adverse Events

Occlusal Adjustmen Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Occlusal Adjustment Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Occlusal Adjustmen Therapy n=39 participants at risk Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)	Placebo Occlusal Adjustment Therapy n=38 participants at risk Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
Musculoskeletal and connective tissue disorders Dental hypersensitivity	7.7% 3/39 • Number of events 3 • 6 months The dental hypersensitivity period (referred to as discomfort to the chewing foods crisp) lasted between 1 and 3 months.	0.00% 0/38 • 6 months The dental hypersensitivity period (referred to as discomfort to the chewing foods crisp) lasted between 1 and 3 months.

Additional Information

Professor Urbano Santana Penín

University of Santiago de Compostela. A Coruña. SPAIN

Phone: +34647344093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place