| CTRI Number |
CTRI/2024/05/067595 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy of two different formulations of tetracycline antibiotic when applied locally in patients with gum disease |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of the Effectiveness of a Novel Local Drug Delivery Agent Containing Tetracycline HCL Micro-particles vs Tetracyline HCL fibers (Periodontal AB plusTM) in Treatment of Periodontal Pockets in Patients with Chronic Periodontitis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mala Dixit Baburaj |
| Designation |
Professor and Head |
| Affiliation |
Professor and Head |
| Address |
201, Department of Periodontics, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mala Dixit Baburaj |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
201, Department of Periodontics, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mala Dixit Baburaj |
| Designation |
Professor and Head |
| Affiliation |
Professor and Head |
| Address |
201, Department of Periodontics, Nair Hospital Dental College, Mumbai Central, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| self sponsored |
| study will be conducted at Nair Hospital Dental College, Mumbai |
|
|
Primary Sponsor
|
| Name |
Mala Dixit Baburaj Primary Investigator |
| Address |
same as above |
| Type of Sponsor |
Other [] |
|
|
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 Mala Dixit Baburaj |
Nair Hospital Dental College |
201, Nair hospital dental college, Mumbai Central, Mumbai-400008
Mumbai (Suburban)
MAHARASHTRA |
9223340938
maladixit25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NHDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
tetracycline fibers marketed as Periodontal AB plus (ICPA PVT LTD) 2 mg |
as local drug delivery agent in isolated periodontal pockets to be delivered once at the base of the pocket |
| Intervention |
Tetracycline microparticles 2mg per pocket |
as local drug delivery agent in isolated periodontal pockets to be delivered once at the base of the pocket |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Isolated periodontal pockets 5mm to 7mm deep.
2) Patients with chronic periodontitis
3) Patient willing to give the informed consent and willing to comply with the study were selected
|
|
| ExclusionCriteria |
| Details |
1) Allergy or hypersensitivity to tetracycline or related compounds.
2) Use of antibiotics within last 3 months.
3) Patients not maintaining satisfactory oral hygiene after phase1 periodontal therapy.
4) Systemic diseases.
5) Pregnancy.
6) Smoking
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pocket Probing Depth customized using acrylic stent
Clinical Attachment level customized using acrylic stent |
at baseline, 3 months, 6 months and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index (Loe and Silness-1964)
Plaque index (TURESKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN) using plaque disclosing tablets (Placksee, ICPA pvt LTD)
|
at baseline, 3 months, 6 months and 9 months |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
The
current study is a Comparative Clinical Evaluation of the Effectiveness of a
Novel Local Drug Delivery Agent Containing Tetracycline HCL Micro-particles vs
Tetracyline HCL fibers (Periodontal AB plusTM) as an adjunct to
mechanotherapy for the Treatment of isolated Periodontal Pockets in Patients
with Chronic Periodontitis. Primary objective: To
evaluate and compare the efficacy of the novel local drug delivery system containing
Tetracycline Hydrochloride Microparticles to commercially available
tetracycline fibers (Periodontal AB PlusTM) as an adjunct to mechanotherapy
in the management of isolated periodontal of chronic periodontitis Study design:The
study is designed an Interventional Prospective Randomized Clinical Study. It
is a single-blinded, single centre, institution-based study. The patients in Group A, [EXPERIMENTAL GROUP]
1. Subgingival curettage will be done under LA infiltration (1 in
1,00,000 adrenaline) using sterile curettes.
2. Tetracycline HCl Micro-particles will be placed in the curetted
pockets
3. Periodontal dressing (Coe-Pak) will be placed over the site.
The patients in Group B [Control GROUP]
1. Subgingival curettage will be done under LA infiltration (1 in
1,00,000 adrenaline) using sterile curettes.
2. Tetracycline HCl fibers (Periodontal AB Plus) will be placed in
the curetted pockets
3. Periodontal dressing (Coe-Pak) will be placed over the site.
·
Patients will be recalled after 1 week for Periodontal dressing removal and
surgical site evaluation
· Oral
hygiene instructions will be reinforced
·
Patients will be followed up for 1 ,3 , 9months following which the clinical
parameters will be reassessed. |