| CTRI Number |
CTRI/2018/05/013930 [Registered on: 17/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of Two Different One-stage Full-mouth Disinfection Protocols by Assessing Dental Plaque and Tongue Coat in the Treatment of Chronic Periodontitis |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different One-stage Full-mouth Disinfection Protocols by Assessing Dental Plaque and Tongue Coat using N-Benzoyl-DL-Arginine-2-Naphthylamide Assay in the Treatment of Chronic Periodontitis - A Randomized Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjumand Farooqui |
| Designation |
Post graduate Student |
| Affiliation |
Department of Periodontics, MGM Dental College and Hospital, Navi Mumbai |
| Address |
M.G.M. Dental College and Hospital, Plot No-01, Sector-01, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
400070
India |
| Phone |
9987382635 |
| Fax |
|
| Email |
arjumand.farooqui@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vineet Kini |
| Designation |
Professor |
| Affiliation |
Department of Periodontics, MGM Dental College and Hospital, Navi Mumbai |
| Address |
M.G.M. Dental College and Hospital, Plot No-01, Sector-01, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
400070
India |
| Phone |
9769804390 |
| Fax |
|
| Email |
drvinkin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjumand Farooqui |
| Designation |
Post graduate Student |
| Affiliation |
Department of Periodontics, MGM Dental College and Hospital, Navi Mumbai |
| Address |
M.G.M. Dental College and Hospital, Plot No-01, Sector-01, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
400070
India |
| Phone |
9987382635 |
| Fax |
|
| Email |
arjumand.farooqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| M. G. M. Dental college and hospital, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Arjumand Farooqui |
| Address |
M. G. M. Dental College and Hospital, Navi MUmbai |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arjumand Farooqui |
M G M Dental college and hospital |
Department of Periodontics, Room No 8, M.G.M. Dental College and Hospital, Plot No-01, Sector-01, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA |
9987382635
arjumand.farooqui@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Review Committee MGM DCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects aged 18-60 years rendering informed consent.
Presence of minimum 20 natural scorable teeth.
Subjects diagnosed with chronic periodontitis based on AAP classification 1999.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% Chlorhexidine Mouthwash (Quirynen Protocol for Full-mouth dinsinfection) |
0.2% Chlorhexidine mouthwash for 2 weeks (Quirynen Protocol for Full-mouth dinsinfection)versus for two months(Bollens Protocol for Full-mouth disinfection |
| Intervention |
0.2% Chlorhexidine Mouthwash(Bollens Protocol for Full-mouth disinfection) |
0.2% Chlorhexidine mouthwash for 2 weeks (Quirynen Protocol for Full-mouth dinsinfection)versus for two months(Bollens Protocol for Full-mouth disinfection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged 18-60 years rendering informed consent.
2. Presence of minimum 20 natural scorable teeth excluding third molars.
3. Subjects diagnosed with chronic periodontitis based on American Academy of Periodontology (AAP) classification 1999.
4. Presence of at least two teeth per quadrant with a probing depth of > 3mm.
5. Subjects having good level of oral hygiene |
|
| ExclusionCriteria |
| Details |
1. Subjects who have received any form of periodontal therapy, surgical or non-surgical within past 6 months.
2. Subjects who have received antibiotic and / or anti-inflammatory therapy within the past 3 months.
39
3. Subjects wearing orthodontic appliances.
4. Subjects suffering from any systemic disease.
5. Subjects who give present or past history of drug abuse.
6. Subjects who give present or past history of Smoking and tobacco consumption.
7. Subjects with untreated grossly carious teeth.
8. Subjects with severe abrasion of teeth.
9. History of known allergies to constituents found in the mouthrinse (0.2% chlorhexidine gluconate) or dentifrice assigned during the intervention.
10. Subjects with a habit of mouth breathing, para-functional habits like bruxism, clenching etc.
11. Subjects with lip piercing and tongue piercing.
12. Pregnant women and lactating mothers.
13. Physically debilitated subjects. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing dental plaque and tongue coat quantitatively through PI at 2 weeks and 6 weeks follow up from baseline, and through WTCI at 2 weeks and 8 weeks follow up from baseline; and qualitatively through BANA assay through BANA P and BANA T scores 8 weeks follow up. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of healing outcomes of change in clinical parameters of GI, SBI, PD, RCAL and GR at 6 weeks from baseline |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
31/05/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The present study was a prospective parallel arm randomized clinical and microbiological study aimed to evaluate and compare Quirynen’s protocol and Bollen’s protocol of one-stage full-mouth disinfection with primary objective of comparing dental plaque and tongue coat quantitatively through PI at 2 weeks and 6 weeks follow up from baseline, and through WTCI at 2 weeks and 8 weeks follow up from baseline; and qualitatively through BANA assay through BANA P and BANA T scores 8 weeks follow up. Secondary objectives were assessment of healing outcomes of change in clinical parameters of GI, SBI, PD, RCAL and GR at 6 weeks from baseline. 40 systemically healthy subjects with chronic periodontitis meeting the inclusion criteria of the study were randomly allocated through computer generated random number sequence method into two treatment intervention groups Group A (Quirynen’s protocol of one-stage full-mouth disinfection ) and Group B ( Bollen’s protocol of one-stage full-mouth disinfection) . Evaluation parameters of PI, GI, SBI, WTCI, PD, and RCAL were recorded at baseline. Following each treatment intervention respective evaluation parameters were recorded for both Group A and Group B at 2 weeks follow up (PI and WTCI) , 6 weeks follow up ( PI, GI, SBI, PD , GR) and at 8 weeks follow up ( WTCI, BANA P and BANA T) from baseline. The data from the above parameters were recorded by a single calibrated examiner and statistically analyzed by a blinded statistician making this a single blinded study.although Quirynen’s protocol did demonstrate a statistically significant reduction in plaque index scores as compared to Bollen’s protocol at 2 weeks follow up and 6 weeks follow up from baseline, the Bollen’s protocol demonstrated superior reduction in gingival index scores at 6 weeks follow up from baseline. The difference in duration and mode of use of chlorhexidine as a chemical plaque control agent in the two treatment interventions of Quirynen’s and Bollen’s protocol of one-stage full-mouth disinfection did not demonstrate statistical significance in reducing sulcus bleeding index scores, reducing probing depths and gain in relative clinical attachment levels at 6 weeks follow up from baseline; No statistical difference was demonstrated between the two one-stage full-mouth disinfection protocols for the BANA P and BANA T scores assessed using chair-side BANA assay of microbial analysis at 8 weeks follow up under the current study settings. |