| CTRI Number |
CTRI/2024/04/065077 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of two different membranes platelet rich fibrin and chorionic membrane to increase the width of gingival mucosa. |
|
Scientific Title of Study
|
Comparison of platelet rich fibrin membrane alone & chorion membrane along with platelet rich fibrin membrane to increase the width of attached gingiva, vestibular depth and gingival thickness. |
| 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. Arti Odedara |
| Designation |
1st year student |
| Affiliation |
Government dental college and hospital jamnagar |
| Address |
Department of Periodontology
Government Dental College & Hospital, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9574958403 |
| Fax |
|
| Email |
odedraartiben@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nayana Patel |
| Designation |
Head Of Department |
| Affiliation |
Government dental college and hospital jamnagar |
| Address |
Department of Periodontology
Government Dental College & Hospital, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Arti Odedara |
| Designation |
1st year student |
| Affiliation |
Government dental college and hospital jamnagar |
| Address |
Department of Periodontology
Government Dental College & Hospital, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9574958403 |
| Fax |
|
| Email |
odedraartiben@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology
Government Dental College Hospital jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Arti Odedra |
| Address |
Department of Periodontology
Government Dental College & Hospital, Jamnagar
|
| Type of Sponsor |
Government 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 |
| Dr Arti odedara |
Government dental college & hospital, jamnagar |
Roo No.102,1st Floor, Department Of Periodontology, Navagam ghed, Opposite to police line, Jamnagar
Jamnagar
GUJARAT |
9574958403
odedraartiben@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree M.P. Shah Govt. Medical College and G.G. Govt. Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PRF group |
Use of PRF in vestibular extension to increase vestibular depth, attached gingiva and gingival thickness. |
| Comparator Agent |
Chorion membrane along with platelet rich fibrin membrane |
Use of chorion membrane along with platelet rich fibrin membrane in vestibular extension procedure to increase the width of attached gingiva, vestibular depth and gingival thickness. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with less than 2 mm width of attached gingiva
Patients having a positive tension test
|
|
| ExclusionCriteria |
| Details |
Patients with history of periodontal treatment in past 6 months, Who were on antibiotics or immunosuppressant medications six months prior to the study, Chronic smokers, alcoholics and smokeless tobacco users, Patients were suffering from any systemic diseases or who were under antibiotics, Physically and mentally disabled patients, Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase the width of attached gingiva |
At baseline, 3 months & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to increase vestibular depth and gingival thickness |
3 and 6 moths |
|
|
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 4 |
|
Date of First Enrollment (India)
|
13/04/2024 |
| 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="2" |
|
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
|
| The data will be collected from the patients with < 2 mm width of attached gingiva will be selected visiting the OPD of the Department of Periodontology, Government Dental College and Hospital, Jamnagar, Gujarat. After informing the patient about the study and completing the formalities in the consent form, the patients will be enrolled and data collection in the proforma will be done. | To Assess the efficacy of platelet rich fibrin and chorionic membrane together in increasing the width of attached gingiva, vestibular depth and gingival thickness. | | |