| CTRI Number |
CTRI/2026/01/100449 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of antibiotic fibers along with routine gum treatment in patients with gum disease |
|
Scientific Title of Study
|
Evaluation of efficacy of adjunctive use of tetracycline fibers in
Periodontitis patients: A Clinico- microbiological study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Ghanshyam |
| Designation |
Post Graduate student |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9149813100 |
| Fax |
|
| Email |
himanshu300jo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Gupta |
| Designation |
Professsor and Head of Department |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9218550007 |
| Fax |
|
| Email |
drrajan68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Gupta |
| Designation |
Professsor and Head of Department |
| Affiliation |
Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh. |
| Address |
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9218550007 |
| Fax |
|
| Email |
drrajan68@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Individual Dr Himanshu Ghanshyam |
| Address |
Himachal Institute Of Dental Science, Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh |
| 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 Himanshu Ghanshyam |
Himachal Institute of Dental Sciences |
Department of Periodontics and Implantology, Room no:-4, Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH |
9149813100
himanshu300jo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIDS Institutional Ethics Committee |
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 |
scaling and root planing |
Nonsurgical periodontal therapy consisting of scaling and root planing was performed at the control sites using ultrasonic scalers and hand instruments. No local drug delivery agent was used. Patients received routine postoperative care and oral hygiene instructions |
| Intervention |
Tetracycline fibres |
collagen fibers impregnated with tetracycline hydrochloride were used as local delivery system . following scaling and root planing the fibers were placed into periodontal pockets. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were non-smokers and patients with no diagnosis of diabetes or other systemic diseases.
Patients having probing depth greater than or equal to 5 mm with evident Clinical attachment loss greater than or equal to 2mm, requiring non-surgical treatment
Patients in whom no post-treatment tooth loss was expected, indicating the case has a good prognosis going into maintenance. |
|
| ExclusionCriteria |
| Details |
Patients allergic to tetracyclines.
Patient with habits like of Smoking or Tobacco chewing or Alcohol
consumption.
Patients with uncontrolled Diabetes, Hypertension.
Patients with Immuno- compromised conditions.
Pregnant or lactating mothers.
Patients who were non-compliant or physically challenged who were not able
to maintain the oral hygiene or not able to follow up for recall visit.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| probing pocket depth reduction |
baseline, one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quantitative reduction in Porphyromonas gingivalis levels (RT-PCR) from baseline to one month |
baseline and one month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
20/01/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This split-mouth randomized controlled clinical trial aims
to evaluate the clinical and microbiological efficacy of Periodontal Plus AB
(tetracycline fibers) as a local drug delivery system when used adjunctively
with scaling and root planing (SRP) in patients with chronic periodontitis. Two
non-adjacent periodontal sites in each patient will be randomly allocated to
receive either SRP alone (control site) or SRP followed by subgingival
placement of Periodontal Plus AB (test site). Clinical parameters including
Approximal Plaque Index (API), Papillary Bleeding Index (PBI), Probing Pocket
Depth (PPD), and Clinical Attachment Level (CAL) will be assessed at baseline
and follow-up intervals. Microbiological assessment of Porphyromonas gingivalis
levels using RT-PCR will be performed at baseline and at 1 month. The study
aims to determine whether adjunctive Periodontal Plus AB provides superior
clinical improvement and microbial reduction compared to SRP alone. |