| CTRI Number |
CTRI/2025/08/093191 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative analysis of Crestal Bone Loss Between Flapless technique, Flap technique and flap with Platelet rich fibrin (PRF) after Implant Placement in edentolus area. participants will be edentulous area. interventions will be impplant placed with and with out mucoperiosteal |
|
Scientific Title of Study
|
To Evaluate the comparative Crestal Bone Loss between flap, flap withPRF and lapless techniquefor implant placement |
| 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.Anjali Kapoor |
| Designation |
Sr. professor |
| Affiliation |
RUHS College of Dental sciences Rajasthan University of Health Scinces |
| Address |
RUHS College of Dental sciences- college of dental sciences
Department of Periodontics , room no 6
vidhayadhar Nagar , papad ke hanumanji jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7790920328 |
| Fax |
|
| Email |
anjalikapoor66@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debopriya Chatterjee |
| Designation |
Asst.proessor |
| Affiliation |
RUHS-college of dental sciences |
| Address |
RUHS College of Dental sciences
Department of Periodontics
oom no 6
397 AB NIRMAN HANAGR JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
07568677717 |
| Fax |
|
| Email |
banerjee.debo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debopriya Chatterjee |
| Designation |
Asst.proessor |
| Affiliation |
RUHS-college of dental sciences |
| Address |
RUHS College of Dental sciences
Department of Periodontics
ROOM NO 6
397 AB NIRMAN HANAGR JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
07568677717 |
| Fax |
|
| Email |
banerjee.debo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
anjali kapoor sel |
| Address |
RUHS College of Dental sciences
Department of Periodontics
room no 6
jaipur 302016 |
| 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 |
| DrDebopriya Chatterjee |
goverment dental college jaipur/ RUHS college of dental sciences |
RUHS College of Dental sciences
Rajasthan University of Health
Sciences. Department Of Periodontics.room no6
Jaipur
RAJASTHAN |
07568677717
banerjee.debo@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajasthan university of Health Sciences - College of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dental implant placed by flapless method: 6 months |
dental implant placed in edentulous area placed by flapless method: 6 months |
| Comparator Agent |
dental implant placed with flap combined with platelet rich fibrin : 6 months |
dental implant placed in edentulous area with flap combined with platelet rich fibrin: 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
sufficient bone height and width
sufficient width of keratinized tissue |
|
| ExclusionCriteria |
| Details |
systemic disease
smokers
pregnant and lactating females |
|
|
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 |
| to assess crestal bone loss radiographically |
to assess crestal bone loss radiographically assesed at baseline , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
osseointegration of dental impant are done using raising mucoperiosteal flap. however raising flap is associated with morbidity and discomfort like crestal bone loss. hence the aim of the study to compare dental implant placed with mucoperiosteal flap and without mucoperoosteal flap. |