| CTRI Number |
CTRI/2025/05/086938 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative clinical and immunological analysis of open flap debridement versus closed debridement using Er:YAG laser in Stage III grade B generalized periodontitis: A randomised controlled clinical trial |
|
Scientific Title of Study
|
Comparative clinical and immunological analysis of open flap debridement versus closed debridement using Er:YAG laser in Stage III grade B generalized periodontitis: A randomised controlled clinical trial |
| Trial Acronym |
Open debridement versus closed debridement |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maj Azhar Khan |
| Designation |
Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Dept of Periodontology
Army Dental Centre
Research and Referral
Dhaula Kuan
New Delhi
South West
DELHI
110010
India |
| Phone |
9596605986 |
| Fax |
|
| Email |
dr.azhar.khan17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col T Prasanth |
| Designation |
HOD |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Dept of Periodontology
Army Dental Centre
Research and Referral
Dhaula Kuan
New Delhi
South West
DELHI
110010
India |
| Phone |
8284851155 |
| Fax |
|
| Email |
tprasanthavin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Azhar Khan |
| Designation |
Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
Dept of Periodontology
Army Dental Centre
Research and Referral
Dhaula Kuan
New Delhi
South West
DELHI
110010
India |
| Phone |
9596605986 |
| Fax |
|
| Email |
dr.azhar.khan17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department equipment fund , Army Dental Centre(Research and Referral), Dhaula kuan, New Delhi- 110010 |
|
|
Primary Sponsor
|
| Name |
Army Dental Centre Research and Referral Dhaula Kuan, New Delhi |
| Address |
Army Dental Centre R and R
Dhaula Kuan
Delhi
110010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Maj Dr Azhar Khan |
Army Dental Centre Research and Referral |
Room 1C, Department of Periodontology, Army Dental Centre(Research and Referral) Dhaula Kuan, New Delhi-110010
South West
DELHI |
9596605986
dr.azhar.khan17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental Centre Research and Referral |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed debridement of the arch with Er:YAG Laser 1 month after phase 1 periodontal therapy. |
In the other half closed debridement with Er:YAG laser after 1 month of phase 1 periodontal therapy will be done. Laser will be used for subgingival calculus removal and pocket debridement. For calculus removal, laser will be used in contact mode at 100mJ, 20Hz and with chisel tip. For periodontal pocket debridement in the contact mode at 60mJ, 20Hz and 0.4x 17mm tip following which periodontal pocket disinfection will be done in contact mode at 40mJ, 20Hz with 0.4x17mm tip. |
| Comparator Agent |
Open flap debridement |
in one half of the arch Full thickness much periosteal flap will be raised using Kirkland flap, root surface debridement will be done. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with PPD equal to or greater than 5mm and equal to or less than 8mm in more than two non adjacent teeth affecting more than 30 percent of teeth. |
|
| ExclusionCriteria |
| Details |
1. History of surgical and nonsurgical periodontal therapy in last 2yrs
2. Past or current tobacco users
3. Pregnant or Expecting or Lactating women
4. Full mouth bleeding score FMBS and Full mouth plaque score FMPS more than 10 percent after Phase I therapy
5. Patients who dont comply with the treatment protocol
6. Patients with co morbidities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pocket probing depth
2. Clinical attachment level
3. Percentage of sites with bleeding on probing
|
Baseline, 3 and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TNF-alpha in GCF |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with Stage III Grade B generalized periodontitis will be selected for split mouth study. After recording the baseline parameters randomization will be done and one arch will be allocated to be treated by open flap debridement and the other arch by closed debridement using Er:YAG laser. The parameters will be recorded again at 3 and 6 months. |