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N/A N=42 Randomized Quadruple-blind Supportive Care

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

Periodontitis · Wound Healing

Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI) — 3; 3; 2; 2 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Alcohol-based Chlorhexidine Gluconate 0.12% (Drug); Alcohol-free Chlorhexidine Gluconate 0.12% (Drug); C31G (Drug)
Age
Adult, Older Adult · 34+ yrs
Sex
All
Sponsor
National and Kapodistrian University of Athens
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)
3; 3; 2; 2; 3; 1
SECONDARY
Plaque Index (PI)
2; 2; 1
SECONDARY
Plaque Area Index (PA%)
22.8; 20.6; 11.2; 32.5; 14.9; 11.2

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.

Eligibility Criteria

Inclusion Criteria

  • 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) 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03119831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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