| CTRI Number |
CTRI/2024/06/068695 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
GUM TREATMENT COMPARISON BETWEEN INJECTIONS AND NEEDLE THERAPY |
|
Scientific Title of Study
|
Comparative analysis of
Injectable platelet rich fibrin (i-PRF) and Microneedling (MN) for gingival augmentation in thin gingival biotype 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 |
Masood Kamal |
| Designation |
Junior Resident |
| Affiliation |
King georges medical university |
| Address |
Department of Periodontology Faculty of Dental Sciences King Georges Medical University,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8750900417 |
| Fax |
|
| Email |
masoodkamalmks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavitra Rastogi |
| Designation |
Professor |
| Affiliation |
King georges medical university |
| Address |
Department of Periodontology Faculty of Dental Sciences King Georges medical university Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415119746 |
| Fax |
|
| Email |
expertperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Masood Kamal |
| Designation |
Junior Resident |
| Affiliation |
King georges medical university |
| Address |
Department of Periodontology Faculty of dental sciences King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8750900417 |
| Fax |
|
| Email |
masoodkamalmks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology Faculty of Dental Sciences King Georges Medical University U.P. Lucknow 226003 India |
|
|
Primary Sponsor
|
| Name |
Masood Kamal |
| Address |
Department of Periodontology Faculty of Dental Sciences King Georges Medical University U.P. Lucknow 226003 India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Masood Kamal |
King Georges Medical University |
Room no.14 Department of Periodontology Faculty of Dental Sciences King Georges Medical University
Lucknow
UTTAR PRADESH |
8750900417
masoodkamalmks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY U.P.,INSTITUTIONAL ETHICS COMMITTEE,LUCKNOW-226003 INDIA |
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 |
| Intervention |
Group 1 Effect of injectable platelet rich fibrin on thin gingival biotype patients
|
i-PRF injections will be given at baseline 15 day and 30 day. Gingival thickness keratinized tissue width will be measured at baseline 1 month 3 month and 6 month |
| Comparator Agent |
Group 2 Effect o microneedling on thin gingival biotype patients |
Microneedling procedure will be done at baseline 15 day and 30 day.Gingival thickness keratinized tissue width will be measured at baseline 1 month 3 month and 6 month
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients with age ≥18 years
(2) Patients with Gingival thickness of the mandibular anterior teeth ≤1.5mm (Seibert and Lindhe-1989).14
(3) Patients with no malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
(4) Systemically healthy patients.
(5) Non-smoker patients.
(6) Patients who will give an informed consent.
|
|
| ExclusionCriteria |
| Details |
(1) Patients with active orthodontic treatment.
(2) Patients with history of previous periodontal surgery in last 6 months.
(3) Patients with any systemic disease affecting periodontal health.
(4) Patients currently using blood thinners.
(5) Patients using any drugs that might lead to gingival enlargement.
(6) Pregnant ladies or lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in gingival thickness and keratinized tissue width will be measured after interventions |
increased gingival thickness and keratinized tissue width will be measured at 1 month 3 month 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes in this trial are Plaque index Gingival index Pocket depth Clinical attachment level |
All above mentioned parameters will be measured at baseline 1 month 3 month 6 month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
20/06/2024 |
| 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="0"
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
|
Gingiva is the part of the oral mucosa that surrounds the necks of the teeth and covers the alveolar processes of the jaws . The gingival biotype has been used to describe the thickness of the gingiva in the faciopalatal dimension. and it is a genetically determined trait. Characteristics of thin gingival biotype - Highly scalloped gingival tissue usually may present with slight gingival recession, Delicate and thin periodontium, Tissue appears friable with a minimal zone of attached gingiva. The response of thin gingival biotype to various stimuli or conditions can differ from that of thicker biotypes. Here are some considerations regarding the tissue response to thin gingival biotype: Increased susceptibility to recession due to trauma from various factors such as toothbrushing, periodontal procedures, or orthodontic treatment. Thin gingival tissues may have a reduced blood supply compared to thicker tissues. This can impair the tissue’s ability to heal and resist infection. Thin gingival biotype be converted or enhanced into thick biotype by following procedures i.e. The use of connective tissue grafts, Acellular dermal matrix , Use of platelet-rich fibrin (PRF) membrane etc. Purpose of the study- Due to the positive effects of i-PRF and microneddling on the biological potential, neoangiogenesis, neocollagenesis and wound-healing because of various cells and growth factors i.e. white blood cells, platelets, transforming growth factor-β and collagen-1 mRNA, platelet-derived growth factors, connective tissue growth factor and fibroblast growth factors . In light of these factors, this study will evaluate the effects of standalone i-prf and microneedling on gingival thickness and keratinized tissue width in individuals with thin gingival biotypes.
|