Trial Outcomes & Findings for Effectiveness of Three Different Mouthrinses in Dental Plaque Control and Early Wound Healing (NCT NCT03119831)

NCT ID: NCT03119831

Last Updated: 2017-08-24

Results Overview

EHI measurements range between 1-5: 1. = Complete flap closure-no fibrin line in interproximal area. 2. = Complete flap closure-fibrin line in interproximal area. 3. = Complete flap closure-fibrin clot in the interproximal area. 4. = Incomplete flap closure-partial necrosis of interproximal tissue. 5. = Incomplete flap closure-complete necrosis of the interproximal tissue.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: Early Wound Healing Index was recorded at the 7th and 14th postsurgical day
• Results posted on: 2017-08-24

Participant Flow

Participant milestones

Measure	C31G (Group A) C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Alcohol-free Chlorhexidine (Group B) Alcohol-free Chlorhexidine Gluconate 0.12% Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Alcohol-based Chlorhexidine (Group C) Alcohol-based Chlorhexidine Gluconate 0.12% Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively
Overall Study STARTED	14	14	14
Overall Study COMPLETED	14	14	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group A n=14 Participants C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically	Group B n=14 Participants Non-alcoholic Chlorhexidine Gluconate 0.12% Non-alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically	Group C n=14 Participants Alcoholic Chlorhexidine Gluconate 0.12% Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically	Total n=42 Participants Total of all reporting groups
Age, Continuous	53 years n=14 Participants	52 years n=14 Participants	49 years n=14 Participants	51 years n=42 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	10 Participants n=14 Participants	11 Participants n=14 Participants	28 Participants n=42 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	4 Participants n=14 Participants	3 Participants n=14 Participants	14 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Smoking status Smoker	5 Participants n=14 Participants	6 Participants n=14 Participants	5 Participants n=14 Participants	16 Participants n=42 Participants
Smoking status Non - smoker	8 Participants n=14 Participants	7 Participants n=14 Participants	8 Participants n=14 Participants	23 Participants n=42 Participants
Smoking status Ex - smoker	1 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	3 Participants n=42 Participants
Surgeon's experience Third year postgraduate residents	11 Participants n=14 Participants	12 Participants n=14 Participants	10 Participants n=14 Participants	33 Participants n=42 Participants
Surgeon's experience First year postgraduate residents	3 Participants n=14 Participants	2 Participants n=14 Participants	4 Participants n=14 Participants	9 Participants n=42 Participants
Type of periodontal surgical intervention Periodontal flap surgery	10 Participants n=14 Participants	12 Participants n=14 Participants	8 Participants n=14 Participants	30 Participants n=42 Participants
Type of periodontal surgical intervention Crown lengthening	4 Participants n=14 Participants	1 Participants n=14 Participants	5 Participants n=14 Participants	10 Participants n=42 Participants
Type of periodontal surgical intervention Combination	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	2 Participants n=42 Participants
Tooth area scheduled for surgery Area #13-17	5 Participants n=14 Participants	4 Participants n=14 Participants	5 Participants n=14 Participants	14 Participants n=42 Participants
Tooth area scheduled for surgery Area #23-27	3 Participants n=14 Participants	2 Participants n=14 Participants	4 Participants n=14 Participants	9 Participants n=42 Participants
Tooth area scheduled for surgery Area #33-37	2 Participants n=14 Participants	3 Participants n=14 Participants	2 Participants n=14 Participants	7 Participants n=42 Participants
Tooth area scheduled for surgery Area #43-47	4 Participants n=14 Participants	5 Participants n=14 Participants	3 Participants n=14 Participants	12 Participants n=42 Participants
Jaw Maxilla	8 Participants n=14 Participants	6 Participants n=14 Participants	9 Participants n=14 Participants	23 Participants n=42 Participants
Jaw Mandible	6 Participants n=14 Participants	8 Participants n=14 Participants	5 Participants n=14 Participants	19 Participants n=42 Participants

PRIMARY outcome

Timeframe: Early Wound Healing Index was recorded at the 7th and 14th postsurgical day

EHI measurements range between 1-5:

1. = Complete flap closure-no fibrin line in interproximal area.

2. = Complete flap closure-fibrin line in interproximal area.

3. = Complete flap closure-fibrin clot in the interproximal area.

4. = Incomplete flap closure-partial necrosis of interproximal tissue.

5. = Incomplete flap closure-complete necrosis of the interproximal tissue.

Outcome measures

Measure	Group A n=14 Participants C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group B n=14 Participants Alcohol-free Chlorhexidine Gluconate 0.12% Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group C n=14 Participants Alcohol-based Chlorhexidine Gluconate 0.12% Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively
Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI) 7 days	3 units on a scale Interval 2.0 to 3.0	3 units on a scale Interval 2.0 to 3.0	2 units on a scale Interval 2.0 to 3.0
Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI) 14 days	2 units on a scale Interval 1.0 to 3.0	3 units on a scale Interval 1.0 to 4.0	1 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: PI was recorded 14 days postoperatively

PI measurements range between 0-3:

0 = No plaque

1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

2. = Moderate accumulation of soft deposits on the tooth and gingival margin which can be seen with the naked eye.

3. = Abundance of soft matter on the tooth and gingival margin.

Outcome measures

Measure	Group A n=14 Participants C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group B n=14 Participants Alcohol-free Chlorhexidine Gluconate 0.12% Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group C n=14 Participants Alcohol-based Chlorhexidine Gluconate 0.12% Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively
Plaque Index (PI)	2 units on a scale Interval 1.0 to 3.0	2 units on a scale Interval 1.0 to 2.0	1 units on a scale Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: PA% was recorded at the 7th and 14th postoperative day

Assessment of the accumulation of dental plaque at buccal tooth surfaces between baseline (immediately before surgery), 7 and 14 days postoperatively. PA% referred at the percentage of the total buccal surface area of the included teeth covered by dental plaque. PA% values range between 0-100%

Outcome measures

Measure	Group A n=14 Participants C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group B n=14 Participants Alcohol-free Chlorhexidine Gluconate 0.12% Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group C n=14 Participants Alcohol-based Chlorhexidine Gluconate 0.12% Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively
Plaque Area Index (PA%) 7 days	22.8 percentage of buccal surface area Interval 14.2 to 46.7	20.6 percentage of buccal surface area Interval 6.3 to 32.2	11.2 percentage of buccal surface area Interval 6.0 to 16.5
Plaque Area Index (PA%) 14 days	32.5 percentage of buccal surface area Interval 17.2 to 44.1	14.9 percentage of buccal surface area Interval 7.6 to 28.6	11.2 percentage of buccal surface area Interval 4.6 to 29.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Plaque samples were collected at the 14th postsurgical day.

Population: The inconsistency between the overall number of participants analyzed and the numbers provided in the rows in the participant flow module is due to the fact that there were no microbiological data from three patients in Group B and from another three participants in Group C, because their pooled plaque samples were destroyed during processing.

Levels of bacterial counts, expressed in total bacterial DNA mass (ng) and total number of bacteria. TBC was evaluated by real-time Polymerase Chain Reaction (PCR).

Outcome measures

Measure	Group A n=14 Participants C31G C31G: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group B n=11 Participants Alcohol-free Chlorhexidine Gluconate 0.12% Alcohol-free Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively	Group C n=11 Participants Alcohol-based Chlorhexidine Gluconate 0.12% Alcohol-based Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postoperatively
Total Bacterial Counts (TBC)	7.584 log10 of copy numbers of bacterial DNA Interval 7.421 to 7.835	7.683 log10 of copy numbers of bacterial DNA Interval 7.425 to 8.046	6.480 log10 of copy numbers of bacterial DNA Interval 5.869 to 7.065

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

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

Dr. Anastasios M. Gkatzonis

Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Greece

Phone: 6976486314

Email: gkatzonis.tasos@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place