| CTRI Number |
CTRI/2025/03/082438 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Recession Coverage Using Conventional and Microsurgical Approach |
|
Scientific Title of Study
|
Comparative Evaluation of Recession Coverage Using Conventional and Microsurgical Approach (Randomised Controlled 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 |
KAJOL KUMARI RAJAK |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Room number 5,3rd floor, unit/department Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07908116238 |
| Fax |
|
| Email |
kajolrajkajol@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SARITA PARIHAR |
| Designation |
Professor |
| Affiliation |
Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Room number 5,3rd floor, unit/department Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8004925677 |
| Fax |
|
| Email |
saritaparihar@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
KAJOL KUMARI RAJAK |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty Of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Room number 5,3rd floor, unit/department Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07908116238 |
| Fax |
|
| Email |
kajolrajkajol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 5,3rd floor, unit/department Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,Varanasi |
|
|
Primary Sponsor
|
| Name |
KAJOL KUMARI RAJAK |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,
Varanasi-221005, UP |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 KAJOL KUMARI RAJAK |
Faculty Of Dental Sciences ,BHU |
Room number 5 ,department/Unit Of Periodontology
Varanasi
UTTAR PRADESH |
07908116238
kajolrajkajol@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, IMS, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
gingival recession coverage using using conventional approach |
patient with miller class 1 or class 2 gingival recession will be selected and recession coverage will be done using connective tissue graft using conventional approach |
| Intervention |
gingival recession coverage using using microsurgical approach |
patient with miller class 1 or class 2 gingival recession will be selected and recession coverage will be done using connective tissue graft using microsurgical approach(loupes and microsurgical instruments) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects diagnosed as having gingival recession miller class 1 and class 2.
2)Subjects with age group 18 YEARS TO 55 YEARS.
3)Subjects with good health without any history of systemic illness.
4)Subjects willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with systemic illness like bleeding disorders etc
2.Pregnant or lactating mothers
3.Subjects with habit of tobacco chewing/smoking
4.Drug or alcohol abuse
5.Subjects with history of allergy
6.Immunocompromised state and debilitating disease
7.Subjects with malposed or crowded tooth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Change in recession depth
-Percentage of root coverage
|
Time Points for change in recession depth is 1 month
Time Points for percentage of root coverage is 1 month.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Change in clinical attachment level
-Change in keratinized tissue
-Patient oriented outcome like aesthetics, pain and discomfort.
|
-Time Points for change in clinical attachment level-is one month.
-Time Points for change in keratinized tissue-is one month
-Time points for patient oriented outcome like aesthetics, pain and discomfort-is 15 days
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="1"
Months="6"
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
|
Miller class 1 or 2 gingival recession sites in
anterior maxilla or mandible will be selected. The receded sites will be
allocated randomly into either group. Group a- test site (Root
coverage will be done with connective tissue graft using microsurgical approach) Group b –control site (Root coverage
will be done with connective tissue graft using conventional approach). CLINICAL PARAMETERS TO BE ASSESSED: Probing depth, Recession
depth ,Recession
width, Width
of attached gingiva, Clinical
attachment level, Width
of keratinised mucosa, Patient
pain experience using VAS scale,Time
required for the procedure, Wound
Healing index. On the day of surgery a palatal connective tissue graft will be harvested
from the area distal to the canine and anterior to the mesial aspect of the
first molar on the same side of the surgery. Incision will be given through microsurgical blades
(in test group), and through 15 no. blades in (control group). Tissue handling will be done through microtissue
forceps (in test groups). All procedures will be done using microsurgical loupes
in (test groups). After stabilizing the graft in the correct position
using 6-0 vicryl sutures, micro sutures will be given using
microsurgical needle holder. (in test group. Conventional 4-0 vicryl sutures will be used in
(control group. The palate will be, then sutured. After 15 days, the periodontal
dressing and sutures will be removed and the patients will be called for
follow-up visits. |