| CTRI Number |
CTRI/2024/04/066042 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISION OF CHLORHEXIDINE SILK SUTURE AND PLAIN SILK SUTURE TO EVALUATE HEALING AFTER THIRD MOLAR EXTRACTION. |
|
Scientific Title of Study
|
Comparison of Efficacy of Chlorhexidine-diacetate Coated Silk Sutures Versus Plain Black Braided Silk Sutures in Post Operative Healing After Impacted Mandibular Third Molar Surgery-A Randomized Clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Sachin Khetani |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,KLE VK INSTITUTE OF DENTAL SCIENCE,
JNMC CAMPUS
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9624918935 |
| Fax |
|
| Email |
Sachin36563656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSanjay S Rao |
| Designation |
PROFESSOR |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,KLE VK INSTITUTE OF DENTAL SCIENCE,
JNMC CAMPUS
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9845454266 |
| Fax |
|
| Email |
Sanjsamuel@Yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSanjay S Rao |
| Designation |
PROFESSOR |
| Affiliation |
KAHERS KLE V.K. INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,KLE VK INSTITUTE OF DENTAL SCIENCE,
JNMC CAMPUS
NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9845454266 |
| Fax |
|
| Email |
Sanjsamuel@Yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,KLE VK INSTITUTE OF DENTAL SCIENCE,BELGAUM,KARNATAKA |
|
|
Primary Sponsor
|
| Name |
KHETANI SACHIN |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,KLE VK INSTITUTE OF DENTAL SCIENCE,BELGAUM,KARNATAKA |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 |
| SACHIN KHETANI |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY |
KLE VK INSTITUTE OF DENTAL SCIENCES
Belgaum
KARNATAKA |
9624918935
Sachin36563656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE, KAHER, BELGAUM, KARNATAKA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A -CHLORHEXIDINE DIACETATE COATED SILK SUTURE |
SUTURES PLACED FOR 7 DAYS . |
| Comparator Agent |
GROUP B-PLAIN BLACK BRAIDED SILK SUTURE |
SUTURES PLACED FOR A DURATION OF 7 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to age category of 18-40 years.
Patient with impacted third molar with moderate Pederson Index .
Patient who have not used antibiotics/antimicrobials or anti-inflammatory drugs for one week before surgery.
Patient with ASA status 1 with normal bleeding and clotting time
Patient with adeqate mouth opening and normal TMJ |
|
| ExclusionCriteria |
| Details |
Patients on drugs that might alter the course of study and affect the healing of the surgical site, e.g. aspirin, NSAIDs, steroids and cytotoxic drugs.
Patients who have taken antibiotics prior, in a span of 2–3 weeks for any head and neck infections or upper respiratory tract (penicillin/cephalosporin).
Patients with poor oral hygiene.
Patients with prior infection. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assesment of healing |
assesment of healing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assesment of local erythema |
on day 0,2 and 7 |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
30/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present
study was a clinical randomized controlled trial of total 46 participants were
categorized into two groups: Group I (Chlorhexidine-diacetate coated black
braided silk suture), Group II (plain black braided silk suture). Follow up
period was on 2nd day and 7th day postoperatively to evaluate local erythema
and infection. There was a significant decrease in the post-op surgical site
erythema and infection on 2nd day and 7th day post operatively in case of Group
1 (chlorhexidine diacetate coated black braided silk suture). This indicated
that using a Chlorhexidine-diacetate coated black braided silk suture after
surgical removal of impacted teeth is found to be an effective and economical
alternative in reducing surgical site infection and erythema.
|