Effectiveness of Three Different Mouthrinses in Dental Plaque Control and Early Wound Healing

NCT03119831 | Completed Results

• 1 other identifier: 269
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: This study compared the effectiveness of three different mouthrinses (alcohol and non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in plaque control and early wound healing, postoperatively. Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42 patients were allocated to three groups assigned to two weeks rinsing after periodontal surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based chlorhexidine 0.12% (group C). At weeks 1 and 2, plaque and early wound healing indices were recorded. At day 14, total bacterial counts were estimated utilizing real - time qPCR. Statistics included linear and generalized linear mixed models.

Conditions

Periodontitis; Wound Healing

Keywords

chlorhexidine; alcohol; C31G; Mouthrinses; Early postsurgical wound healing

Outcome Measures

Primary Outcomes (1)

• Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)

  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.

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

Secondary Outcomes (2)

• Plaque Index (PI)

  PI was recorded 14 days postoperatively

• Plaque Area Index (PA%)

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

Other Outcomes (1)

• Total Bacterial Counts (TBC)

  Plaque samples were collected at the 14th postsurgical day.

Study Arms (3)

C31G (Group A)

EXPERIMENTAL

C31G

Drug: C31G

Alcohol-free Chlorhexidine (Group B)

EXPERIMENTAL

Alcohol-free Chlorhexidine Gluconate 0.12%

Drug: Alcohol-free Chlorhexidine Gluconate 0.12%

Alcohol-based Chlorhexidine (Group C)

EXPERIMENTAL

Alcohol-based Chlorhexidine Gluconate 0.12%

Drug: Alcohol-based Chlorhexidine Gluconate 0.12%

Interventions

Alcohol-based Chlorhexidine Gluconate 0.12% DRUG

Rinsing with 15ml for one minute twice daily for 14 days

Alcohol-based Chlorhexidine (Group C)

Alcohol-free Chlorhexidine Gluconate 0.12% DRUG

Rinsing with 15ml for one minute twice daily for 14 days

Alcohol-free Chlorhexidine (Group B)

C31G DRUG

Rinsing with 15ml for one minute twice daily for 14 days

C31G (Group A)

Eligibility Criteria

• Age: 34 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of periodontal pocket elimination / reduction or surgical crown lengthening with or without osseous surgery in one of the following regions: #13-15 or #23-25 or #33-35 or #43-45.
• In cases of pocket elimination / reduction, at least two teeth with ≥ 1 residual periodontal pocket ≥ 5mm and bleeding on probing was mandatory.
• Width of keratinized tissues ≥ 2mm around teeth included in the operated area.
• Cause - related therapy should be completed ≥ 6 weeks before surgical procedure.
• Plaque Index (O'Leary et al. 1972) \< 25% and Gingival Bleeding Index (Ainamo and Bay 1975) \< 25% in whole dentition should be achieved.

You may not qualify if:

• Uncontrolled diabetes mellitus type 1 or 2 (HbA1c \> 7%).
• Smoking \> 20 cigarettes/day.
• Systemic antimicrobial therapy the last 3 months before the surgical procedure.
• Steroidal or/and non - steroidal anti-inflammatory drug therapy the last 15 days.
• Immunodeficiency or immunosuppressive drug therapy.
• History or current chemotherapy or/and radiation therapy.
• Oral bisphosphonates intake \> 3 years or intravenous bisphosphonates therapy.
• Pregnancy or/and breastfeeding.
• Need for osseous graft and/or membrane or any other regenerative material application.
• Furcation involvement of first maxillary premolars and furcation involvement \> class I at the mesial entrance of first maxillary molars.
• Missing teeth, fixed partial dentures, removable dentures or orthodontic brackets in the candidate regions for periodontal surgery.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Ethanol; C 31G

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Anastasios M. Gkatzonis
• Organization: Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Greece

gkatzonis.tasos@gmail.com

6976486314

Study Officials

• Phoebus N Madianos, Professor

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 19, 2017
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-07