| CTRI Number |
CTRI/2025/09/094173 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing gum and bone healing after surgery for gum disease, with or without medicine support before the procedure |
|
Scientific Title of Study
|
Effectiveness of prior local doxycycline application in periodontal sites to be treated with Guided Tissue Regeneration – a parallel arm randomized controlled double blinded trial |
| Trial Acronym |
DOX-GTR Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Athul Krishna P |
| Designation |
Postgraduate Student, Department of Periodontics |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Department of Periodontics, Government Dental College,
Arpookkara, Kottayam, Kerala 686008, India
Kottayam
KERALA
686008
India |
| Phone |
07994277322 |
| Fax |
|
| Email |
athulkrishnaathul773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BAIJU RM |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Department of Periodontics, Government Dental College,
Arpookkara, Kottayam, Kerala 686008, India
Kottayam
KERALA
686008
India |
| Phone |
9447279605 |
| Fax |
|
| Email |
baijurm2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BAIJU RM |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Department of Periodontics, Government Dental College,
Arpookkara, Kottayam, Kerala 686008, India
Kottayam
KERALA
686008
India |
| Phone |
9447279605 |
| Fax |
|
| Email |
baijurm2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Athul krishna P |
| Address |
Department of Periodontics, Government Dental College,
Arpookkara, Kottayam, Kerala – 686008, India |
| 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 |
| Dr Athul Krishna P |
Government Dental College, Kottayam |
Department of Periodontics,
Postgraduate Clinic, Room No. 802, 2nd Floor,
Government Dental College,
Arpookkara, Kottayam, Kerala 686008, India
Kottayam
KERALA |
7994277322
athulkrishnaathul773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Government Dental College,Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline + Guided Tissue Regeneration (GTR with xenograft and resorbable membrane) |
Preoperative subgingival application of locally delivered doxycycline gel into the periodontal pocket, followed by surgical debridement and Guided Tissue Regeneration using Perioglass (bone xenograft) and a bioresorbable membrane. |
| Comparator Agent |
Guided Tissue Regeneration (GTR with xenograft and resorbable membrane) |
Subgingival debridement followed by surgical debridement and Guided Tissue Regeneration using Perioglass (bone xenograft) and a bioresorbable membrane, without doxycycline gel application. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25 years and 60 years.
Both male and female patients.
Patients diagnosed with Stage III or Stage IV periodontitis with two-walled or three-walled infrabony defects, or mandibular molar Class II furcation defects.
Full mouth plaque score and full mouth bleeding score less than 15 percent at the time of enrollment.
At least one tooth with probing pocket depth more than or equal to 6 millimeters with the above mentioned defects.
Patients willing to undergo surgical intervention and attend follow up visits |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to doxycycline or other drugs in the same class.
Smokers who consume more than ten cigarettes per day.
Patients with uncontrolled diabetes that may affect periodontal healing.
Pregnant or lactating women.
Patients with a history of periodontal surgery in the last twelve months at the same site.
Patients with poor plaque control despite oral hygiene instructions. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level gain at six months post surgery |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in probing pocket depth |
Baseline and 6 months post surgery |
| Change in gingival recession |
Baseline and 6 months post surgery
|
Change in bleeding on probing score
|
Baseline and 6 months post surgery |
Radiographic bone fill
|
Baseline and 6 months post surgery |
Change in defect angle
|
Baseline and 6 months post surgery |
Early wound healing index
|
1 week post surgery |
Post operative discomfort assessed by visual analogue scale
|
1 week post surgery |
Change in Porphyromonas gingivalis load assessed by real time PCR
|
Baseline and 1 month post surgery |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized controlled clinical trial aims to evaluate the effectiveness of prior local doxycycline application in periodontal sites treated with guided tissue regeneration (GTR) for management of furcation defects. The study hypothesis is that adjunctive use of local doxycycline before GTR will result in improved clinical attachment level gain, probing pocket depth reduction, and radiographic bone fill compared to GTR alone. A total of 68 participants will be enrolled and followed up for six months to assess clinical, radiographic, and microbiological outcomes. |