| CTRI Number |
CTRI/2020/12/029619 [Registered on: 07/12/2020] Trial Registered Prospectively |
| Last Modified On: |
05/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Low Level Laser Therapy and Platelet Rich Fibrin on Donor site Healing after Vascularised Interpositional Periosteal Connective Tissue Flap |
|
Scientific Title of Study
|
Evaluation of Low Level Laser Therapy and Platelet Rich Fibrin on Donor site Healing after Vascularised Interpositional Periosteal Connective Tissue Flap: A Clinical Studyâ€
|
| Trial Acronym |
LLLT vs PRF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SADAF MUKHTAR |
| Designation |
PG 1ST YEAR |
| Affiliation |
SARASWATI DENTAL COLLEGE |
| Address |
SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
drsadaf323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEK KUMAR BAINS |
| Designation |
PROFESSOR |
| Affiliation |
SARASWATI DENTAL COLLEGE |
| Address |
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
vivekbains@saraswaticolleges.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIVEK KUMAR BAINS |
| Designation |
PROFESSOR |
| Affiliation |
SARASWATI DENTAL COLLEGE |
| Address |
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
|
| Fax |
|
| Email |
vivekbains@saraswaticolleges.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
saraswati dental college |
| Address |
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028 |
| Type of Sponsor |
Other [dental 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 VIVEK KUMAR BAINS |
SARASWATI DENTAL COLLEGE |
DEPARTMENT OF PERIODONTOLOGY, SARASWATI DENTAL COLLEGE, 233, TIWARI GANJ, FAIZABAD ROAD, CHINHAT, LUCKNOW, 226028
Lucknow
UTTAR PRADESH |
9935023439
vivekbains@saraswaticolleges.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
maxillary anterior ridge deficiency |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group I |
Vascularised interpositional periosteal - connective tissue flap (VIP-CT) with Platelet Rich Fibrin(PRF) |
| Comparator Agent |
GROUP II- |
Vascularised interpositional periosteal - connective tissue flap (VIP-CT) with Low Level Laser Therapy (LLLT) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy subjects (ASA-1) with no contraindication for periodontal surgery
Presenting defects in maxillary anterior region requiring either implant placement or fixed prosthetic rehabilitation.
|
|
| ExclusionCriteria |
| Details |
Any systemic disease that can interfere with surgical procedure.
Smokers, Pregnant ladies and lactating women.
Patient taking any medicine that can modify the results.
History of bruxism / parafunctional habits.
|
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the primarily outcome of the study LLLT irradiation can
accelerate wound healing on palatine mucosa after VIP-CT |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction is better for laser as compared to PRF |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In the maxillary anterior are volumertic alteration of the alveolar ridge and asscociated soft tissue defect may be unfavourable for endoosseous implant placement and prosthetic restoration . therefore, soft and hard tissue augmentation may be necesaary for long time survival and esthetic result . VIP-CT flap is a well nourished anteriorly pediculated connective tissue from palate that has the ability to perform large volume soft tissue augmentation at estethic sites with a single procedure.results in simulatenous hard and soft tissue augmentation completion within 4-6 months |