| CTRI Number |
CTRI/2025/03/082987 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing accumulation of bacterial growth on different types of sutures used in surgeries of chronic periodontitis patients. |
|
Scientific Title of Study
|
Comparative assessment of bacterial accumulation on prolene 3-0
suture and silk 3-0 suture following flap surgery in chronic
Periodontitis Patients A Randomized Clinical Trial |
| 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.IYYAPPAN R |
| Designation |
2nd Year Postgraduate Student |
| Affiliation |
Nair Hospital Dental College Mumbai |
| Address |
2nd floor, 201 Department of Periodontics, Nair Hospital Dental college, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
09994007674 |
| Fax |
|
| Email |
iyyappan14ram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneeta Kamble |
| Designation |
Associate Professor |
| Affiliation |
Nair Hospital Dental College Mumbai |
| Address |
2nd floor, 201 Department of Periodontics, Nair Hospital Dental College, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Praneeta Kamble |
| Designation |
Associate Professor |
| Affiliation |
Nair Hospital Dental College Mumbai |
| Address |
2nd floor, 201 Department of Periodontics, Nair Hospital Dental College, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.Iyyappan .R , Room no. 201, Nair Hospital Dental College Mumbai, 400008, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
DrIyyappanR |
| Address |
Room 201, Second floor, Department of Periodontics, Nair Hospital Dental College, Mumbai |
| 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 |
| DRIYYAPPANR |
Nair Hospital Dental College Mumbai |
Room no 201, Second floor, Department of Periodontics,
Nair Hospital Dental College, mumbai central, Mumbai
Mumbai
MAHARASHTRA |
9994007674
iyyappan14ram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
Prolene |
3-0 monofilament Prolene suture
Total Duration of study is 18 months |
| Intervention |
Silk suture |
3-0 multibraided silk suture
Total Duration of study is 18 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients in the age group between 20-60 yrs.
2)Patients diagnosed with Chronic Periodontitis.
3)Patients who are non smokers or do not consume tobacco in any
other form.
4)Patients in good systemic health with no contraindication to
periodontal surgery.
5) Patients having pocket depths greater than5mm.
6) Involved teeth to be vital and asymptomatic. |
|
| ExclusionCriteria |
| Details |
Patients suffering from any systemic diseases or with a
compromised immune system.
2)Patients who has received any type of periodontal surgery for the
past 6 months.
3)Patients taking immunosuppressant drugs like corticosteroids.
4) Patients with a known history of allergy to Doxycycline or
Chlorhexidine or any other medicine used in the study.
5) Patients showing unacceptable oral hygiene compliance during /
after Phase I periodontal therapy.
6) Patients taking any drug known to cause gingival enlargement.
7)Pregnant and/or lactating mothers.
8)Patients with any active oral or periodontal lesions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic periodontitis patients
2) To compare the bacterial accumulation on prolene 3-0 suture and silk 3-0 suture following flap surgery in chronic periodontitis patients |
At baseline, 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival index, Probing pocket depth |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="9"
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
|
Periodontitis is a multifactorial disease resulting in inflammation and
destruction of the connective tissue attachment of the teeth.
Periodontal pocket formation is usually a sequalae of the disease.
The periodontal flap is one of the most frequently employed
procedures, particularly in deep periodontal pockets. Flap surgery for
periodontal re-attachment, demands close post-operative adaptation
of gingival connective tissue on to the tooth surface .1 This study is an institutional based Interventional Prospective
Randomized Clinical Trial
The patients will be selected as per the inclusion and
exclusion criteria, and randomly allotted by a computerized
automated randomization method into 2 groups, Group A and
Group B, and treated as follow.
Group A: Open flap debridement in which flaps will be
approximated by silk 3-0 suture.
Group B - Open flap debridement in which flaps will be
approximated by prolene 3-0 suture. |