| CTRI Number |
CTRI/2023/05/052185 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between Conventional and Paralleling frenectomy techniques |
|
Scientific Title of Study
|
Comparative clinical evaluation of maxillary labial frenum position after frenectomy using conventional and paralleling technique – 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 |
GAURI UGALE |
| Designation |
PROFESSOR |
| Affiliation |
MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, LATUR |
| Address |
DEPARTMENT OF PERIODONTOLOGY, MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH
Latur
MAHARASHTRA
413512
India |
| Phone |
9130009068 |
| Fax |
|
| Email |
ugalegauri@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surbhi Patil |
| Designation |
Postgraduate student |
| Affiliation |
MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, LATUR |
| Address |
Room no 10 department of Periodontics MIDSR Dental college MIT Medical college campus Ambajogai road Latur,
Room no 10 department of Periodontics MIDSR Dental college MIT Medical college campus Ambajogai road Latur,
Latur
MAHARASHTRA
413512
India |
| Phone |
07350844732 |
| Fax |
|
| Email |
surbhipatil01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GAURI UGALE |
| Designation |
PROFESSOR |
| Affiliation |
MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, LATUR |
| Address |
DEPARTMENT OF PERIODONTOLOGY, MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH
Latur
MAHARASHTRA
413512
India |
| Phone |
9130009068 |
| Fax |
|
| Email |
ugalegauri@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MIDSR Dental college MIT medical campus ambajogai road latur |
|
|
Primary Sponsor
|
| Name |
maharshtra institute of dental sciences |
| Address |
MIDSR Dental college MIT medical campus ambajogai road latur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Gauri Ugale |
MIDSR Dental hospital |
MIDSR DentaRoom No 10, Department of Periodontics MIT Medical college campus Ambajogai Road Latur
Latur
MAHARASHTRA
Latur
MAHARASHTRA |
9130009068
ugalegauri@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee MIDSR Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maxillary labial frenectomy |
Maxillary labial frenectomy procedure in papillary frenal attachment using Paralleling technique
18 months |
| Comparator Agent |
Maxillary labial frenectomy |
Maxillary labial frenectomy procedure in papillary type of frenal attachment using Conventional technique
18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Both male and female with ages ranging from 18-50 years.
2. Systemically healthy subjects
3. Periodontally healthy, Stage I periodontitis patients (periodontal pocket < 4 mm in relation to maxillary anterior teeth)
4. Subjects with no bleeding disorders or allergy to any drugs
5. Papillary type of frenal attachment (according to Placek Mirko classification of frenum)
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria :
1. History of antibiotics, anti-inflammatory or any other drugs that alter wound healing in the last one month.
2. History of any periodontal surgical procedure in the last six months in the concerned area.
3. Pregnant women, lactating females and women taking oral contraceptive pills.
4. Subjects who are smokers and consume tobacco in any form
5. Medically compromised patients, mentally challenged person.
6. Missing or mobile maxillary anterior teeth or fracture /attrition of the incisal edges during the course of treatment.
7. Patients with cleft lip or palate
8. Y-shaped frenum
9. With unacceptable oral hygiene (PI>2, GI>2)
10. Patient undergoing active orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the maxillary labial frenum position from fixed reference to its insertion point before and after frenectomy using conventional and paralleling technique |
Preoperatively and 3 months postsurgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the early wound healing score after maxillary labial frenectomy using conventional & paralleling technique |
next day, one week and after one month |
| To evaluate & compare the pain experience with visual analogue scale after maxillary labial frenectomy using conventional and paralleling technique |
till one week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
04/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in a clinical settings of department of periodontics on patients diagnosed with papillary type of frenal attachment. It is a randomized clinical trial with parallel arm in which participants will be allocated into two groups i.e. Group I - Frenectomy with Conventional technique, Group II - Frenectomy with Paralleling technique. Patients fulfilling the inclusion criteria and signing the informed consent will be included. Treatment outcomes will be evaluated in terms of clinical parameters at 1 and 3 months post surgery. Clinical parameters - Evaluation of frenum position, early wound healing score, Pain experienced, Oral hygiene status |