| CTRI Number |
CTRI/2025/04/085207 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Tetracycline coated suture versus silk suture in oral implantology |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of tetracycline coated sutures and non-coated silk sutures on bacterial load reduction in oral implantology: A 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 Kesang Lhamu |
| Designation |
Post Graduate |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of Periodontology and Oral Implantology
Room no 7 MMCDSR Mullana
Ambala
HARYANA
133207
India |
| Phone |
8826169978 |
| Fax |
|
| Email |
kesang.lhamu.11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kesang Lhamu |
| Designation |
Post Graduate |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of Periodontology and Oral Implantology
Room no 7 MMCDSR Mullana
Ambala
HARYANA
133207
India |
| Phone |
8826169978 |
| Fax |
|
| Email |
kesang.lhamu.11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kochar |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of Periodontology and Oral Implantology
Room no 7 MMCDSR Mullana
Ambala
HARYANA
133207
India |
| Phone |
9991099901 |
| Fax |
|
| Email |
drdeepakkochar77@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Department of Periodontology and Oral Implantology
Room no 7 Maharishi Markandeswar College of Dental sciences and research
Mullana Ambala 133207 |
| 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 |
| Dr Kesang Lhamu |
Maharishi Markandeshwar College of Dental Sciences and Research |
Department of Periodontology and Oral implantology
Room no 7 MMCDSR Mullana Ambala
Ambala
HARYANA |
8826169978
Kesang.lhamu.11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with missing tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non- coated silk suture |
To count the Colony forming unit after seven days of placement of non coated silk suture in patients having one or more missing tooth |
| Intervention |
Tetracycline coated suture |
To count the colony forming unit after seven days of placement of tetracycline coated suture in patients having one or more missing tooth
patient recalled after seven days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
above 18 years of age
both male and female patients
co operative and motivational patients committed to oral hygiene
patients having single or multiple missing teeth requiring prosthesis |
|
| ExclusionCriteria |
| Details |
patients with known allergy to tetracycline
patients with any systemic diseases
smokers alcoholics and patients with other adverse habits
pregnant and lactating women
patients with periodontitis and deep carious lesion
intake of any antibiotics three months prior to implant surgery
patients taking corticosteriods immunosuppresents and any other drug that could influence the outcome of the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the colony forming unit in tetracycline coated silk suture and non coated silk suture after implant placement |
7 days after placement of sutures patients will be recalled and the samples will be sent for microbiological analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient subjective opinion will be assessed with a questionnaire based on visual analogue scale |
7 days after placement of suture patients will be recalled & the samples will be sent for microbiological analysis |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
15/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To compare and evaluate the efficacy of tetracycline coated sutures and non coated silk sutures on bacterial load reduction after implant placement with the help of microbiological analysis Twenty patients with one or more missing teeth will be randomly divided into two groups and will be given tetracycline coated sutures or non coated silk sutures after one week the sutures will be removed and send for microbiological analysis Null hypotheses is that there is no comparable differences were seen with the tetracycline coated and non coated silk suture
|