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

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ClinicalTrials.gov Identifier: NCT03119831
Recruitment Status : Completed
First Posted : April 19, 2017
Results First Posted : July 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Anastasios M. Gkatzonis, MSc, National and Kapodistrian University of Athens

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.


Condition or disease Intervention/treatment Phase
Periodontitis Wound Healing Drug: Alcohol-based Chlorhexidine Gluconate 0.12% Drug: Alcohol-free Chlorhexidine Gluconate 0.12% Drug: C31G Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Clinical Trial on the Effectiveness of Three Different Mouthrinses, Adjunct to Periodontal Surgery, in Dental Plaque Control and Early Wound Healing
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: C31G (Group A)
C31G
Drug: C31G
Rinsing with 15ml for one minute twice daily for 14 days
Experimental: Alcohol-free Chlorhexidine (Group B)
Alcohol-free Chlorhexidine Gluconate 0.12%
Drug: Alcohol-free Chlorhexidine Gluconate 0.12%
Rinsing with 15ml for one minute twice daily for 14 days
Experimental: Alcohol-based Chlorhexidine (Group C)
Alcohol-based Chlorhexidine Gluconate 0.12%
Drug: Alcohol-based Chlorhexidine Gluconate 0.12%
Rinsing with 15ml for one minute twice daily for 14 days



Primary Outcome Measures :
  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) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Plaque Index (PI) [ Time Frame: 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.

  2. Plaque Area Index (PA%) [ Time Frame: 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%


Other Outcome Measures:
  1. Total Bacterial Counts (TBC) [ Time Frame: Plaque samples were collected at the 14th postsurgical day. ]
    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).



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Ages Eligible for Study:   34 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) < 25% and Gingival Bleeding Index (Ainamo and Bay 1975) < 25% in whole dentition should be achieved.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119831


Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
Study Chair: Phoebus N Madianos, Professor Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Greece

Responsible Party: Anastasios M. Gkatzonis, MSc, DDS, MSc, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03119831     History of Changes
Other Study ID Numbers: 269
First Posted: April 19, 2017    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: August 24, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anastasios M. Gkatzonis, MSc, National and Kapodistrian University of Athens:
chlorhexidine
alcohol
C31G
Mouthrinses
Early postsurgical wound healing

Additional relevant MeSH terms:
Wounds and Injuries
Periodontitis
Dental Plaque
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents