Trial Outcomes & Findings for Basic Study of Fabricating Biomorphic Crowns (NCT NCT02609178)

Last Updated: 2016-08-02

Results Overview

Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients' occlusal contact pattern; and some have considered it as a capable description of occlusion. In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician. △OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

2 weeks(plus or minus 7 days) after tooth preparation

Results posted on

2016-08-02

Participant Flow

All the participants were enrolled from the Department of Prosthodontics, Stomatological Hospital of Fourth Military Medical University between December 2015 and March 2016.

17 patients assessed for eligibility, 5 of them were excluded for not meeting inclusion criteria. 12 participants recruited; 10 screened.

Participant milestones

Participant milestones
Measure	FGP First, Then CON, Then AVR Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.	AVR First, Then FGP, Then CON Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.	AVR First, Then CON, Then FGP Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.	CON First, Then AVR, Then FGP Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
First Crown STARTED	1	6	3	2
First Crown COMPLETED	1	5	2	2
First Crown NOT COMPLETED	0	1	1	0
5-minute Washout Time STARTED	1	5	2	2
5-minute Washout Time COMPLETED	1	5	2	2
5-minute Washout Time NOT COMPLETED	0	0	0	0
Second Crown STARTED	1	5	2	2
Second Crown COMPLETED	1	5	2	2
Second Crown NOT COMPLETED	0	0	0	0
Third Crown STARTED	1	5	2	2
Third Crown COMPLETED	1	5	2	2
Third Crown NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FGP First, Then AVR, Then CON Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.	FGP First, Then CON, Then AVR Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.	AVR First, Then FGP, Then CON Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.	AVR First, Then CON, Then FGP Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.	CON First, Then FGP, Then AVR Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.	CON First, Then AVR, Then FGP Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
First Crown Withdrawal by Subject	0	0	1	1	0	0

Baseline Characteristics

Basic Study of Fabricating Biomorphic Crowns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Occlusal Surface Design n=12 Participants use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment China	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks(plus or minus 7 days) after tooth preparation

Population: Including participants who tried in all of the three differently designed artificial crowns.

Outcome measures

Outcome measures
Measure	FGP Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by FGP technique.	AVR Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.	CON Designed Surface n=10 Participants The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
△OT Value	0.07 seconds Standard Deviation 0.09	0.13 seconds Standard Deviation 0.06	0.22 seconds Standard Deviation 0.10

PRIMARY outcome

Timeframe: 2 weeks(plus or minus 7 days) after tooth preparation

Population: Including participants who tried in all of the three differently designed artificial crowns.

Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders. In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician. △DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)

Outcome measures

Outcome measures
Measure	FGP Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by FGP technique.	AVR Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.	CON Designed Surface n=10 Participants The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
△DT Value	0.09 seconds Standard Deviation 0.51	0.49 seconds Standard Deviation 0.58	1.02 seconds Standard Deviation 0.69

SECONDARY outcome

Timeframe: 2 weeks(plus or minus 7 days) after tooth preparation

Population: Including participants who tried in all of the three differently designed artificial crowns.

Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.

Outcome measures

Outcome measures
Measure	FGP Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by FGP technique.	AVR Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.	CON Designed Surface n=10 Participants The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
Occlusal Adjusting Time for Crowns	5.4 minutes Standard Deviation 3.8	6.1 minutes Standard Deviation 4.8	12.6 minutes Standard Deviation 5.3

SECONDARY outcome

Timeframe: 2 weeks(plus or minus 7 days) after tooth preparation

Population: Including participants who tried in all of the three differently designed artificial crowns.

The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire: Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)

Outcome measures

Outcome measures
Measure	FGP Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by FGP technique.	AVR Designed Surface n=10 Participants The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.	CON Designed Surface n=10 Participants The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
Likert's Scale Score 1	5 participants	5 participants	1 participants
Likert's Scale Score 0	4 participants	3 participants	0 participants
Likert's Scale Score 2	1 participants	2 participants	9 participants

Adverse Events

Occlusal Surface Design

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pingting Lin, PhD

Stomatological Hospital of FMMU

Phone: +86 15249049902

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place