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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Periodontitis
Wound Healing
Interventions: Drug: Alcohol-based Chlorhexidine Gluconate 0.12%
Drug: Alcohol-free Chlorhexidine Gluconate 0.12%
Drug: C31G

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    C31G (Group A)   Alcohol-free Chlorhexidine (Group B)   Alcohol-based Chlorhexidine (Group C)
STARTED   14   14   14 
COMPLETED   14   14   14 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group A

C31G

C31G: Rinsing with 15ml for one minute twice daily for 14 days postsurgically

Group B

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

Alcoholic Chlorhexidine Gluconate 0.12%

Alcoholic Chlorhexidine Gluconate 0.12%: Rinsing with 15ml for one minute twice daily for 14 days postsurgically

Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Group C   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   14   42 
Age 
[Units: Years]
Median (Inter-Quartile Range)
       
Participants Analyzed   14   14   14   42 
   53 
 (43 to 58) 
 52 
 (49 to 59) 
 49 
 (43 to 55) 
 51 
 (45 to 58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Female      7  50.0%      10  71.4%      11  78.6%      28  66.7% 
Male      7  50.0%      4  28.6%      3  21.4%      14  33.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed   0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Smoking status 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Smoker      5  35.7%      6  42.9%      5  35.7%      16  38.1% 
Non - smoker      8  57.1%      7  50.0%      8  57.1%      23  54.8% 
Ex - smoker      1   7.1%      1   7.1%      1   7.1%      3   7.1% 
Surgeon's experience 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Third year postgraduate residents      11  78.6%      12  85.7%      10  71.4%      33  78.6% 
First year postgraduate residents      3  21.4%      2  14.3%      4  28.6%      9  21.4% 
Type of periodontal surgical intervention 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Periodontal flap surgery      10  71.4%      12  85.7%      8  57.1%      30  71.4% 
Crown lengthening      4  28.6%      1   7.1%      5  35.7%      10  23.8% 
Combination      0   0.0%      1   7.1%      1   7.1%      2   4.8% 
Tooth area scheduled for surgery [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Area #13-17      5  35.7%      4  28.6%      5  35.7%      14  33.3% 
Area #23-27      3  21.4%      2  14.3%      4  28.6%      9  21.4% 
Area #33-37      2  14.3%      3  21.4%      2  14.3%      7  16.7% 
Area #43-47      4  28.6%      5  35.7%      3  21.4%      12  28.6% 
[1]

According to FDI World Dental Federation enumeration system:

  • Area #13-17: Maxillary right canine - maxillary right second molar
  • Area #23-27: Maxillary left canine - maxillary left second molar
  • Area #33-37: Mandibular left canine - mandibular left second molar
  • Area #43-47: Mandibular right canine - mandibular right second molar
Jaw 
[Units: Participants]
Count of Participants
       
Participants Analyzed   14   14   14   42 
Maxilla      8  57.1%      6  42.9%      9  64.3%      23  54.8% 
Mandible      6  42.9%      8  57.1%      5  35.7%      19  45.2% 


  Outcome Measures

1.  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)   [ Time Frame: Early Wound Healing Index was recorded at the 7th and 14th postsurgical day ]

2.  Secondary:   Plaque Index (PI)   [ Time Frame: PI was recorded 14 days postoperatively ]

3.  Secondary:   Plaque Area Index (PA%)   [ Time Frame: PA% was recorded at the 7th and 14th postoperative day ]

4.  Other Pre-specified:   Total Bacterial Counts (TBC)   [ Time Frame: Plaque samples were collected at the 14th postsurgical day. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Anastasios M. Gkatzonis
Organization: Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Greece
phone: 6976486314 ext 0030
e-mail: gkatzonis.tasos@gmail.com



Responsible Party: Anastasios M. Gkatzonis, MSc, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03119831     History of Changes
Other Study ID Numbers: 269
First Submitted: April 9, 2017
First Posted: April 19, 2017
Results First Submitted: April 22, 2017
Results First Posted: July 24, 2017
Last Update Posted: August 24, 2017