| CTRI Number |
CTRI/2025/04/084600 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mid Crestal Flap, Buccal Roll Flap and Modified Punch Technique on Soft and Hard Tissues in Single Stage Dental Implants |
|
Scientific Title of Study
|
Comparative Evaluation of Soft and Hard Tissues in Mid
Crestal Flap, Buccal Roll Flap and Modified Punch Technique
in Single Stage Dental Implants: Randomized 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 |
Dr Payal Ninawe |
| Designation |
Post-Graduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Government Dental College and Hospital, Nagpur
Medical College Premises, Medical Square, Nagpur Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8097635808 |
| Fax |
|
| Email |
drpayalninawe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital,Nagpur |
| Address |
Department of Periodontology ,Government Dental College and Hospital, Nagpur
Medical College Premises, Medical Square, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8299282002 |
| Fax |
|
| Email |
pdewanzee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Ninawe |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Government Dental College and Hospital, Nagpur
Medical College Premises, Medical Square, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8097635808 |
| Fax |
|
| Email |
drpayalninawe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Government Dental College and Hospital Nagpur, Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 |
|
|
Primary Sponsor
|
| Name |
Dr Payal Ninawe |
| Address |
Department of Periodontology, Government Dental College and Hospital, Nagpur |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Payal Ninawe |
Government Dental College and Hospital, Nagpur |
202,Department of Periodontology, Govt. Dental College and Hospital, Medical College Premises, Medical Square, Nagpur
Nagpur
MAHARASHTRA |
8097635808
drpayalninawe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z965||Presence of tooth-root and mandibular implants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dental Implant Placement by Buccal Roll Flap and Modified Punch Technique |
After explaining the study to the patient , an informed consent will be taken from the patient before the start of the study.At site of missing tooth, In buccal roll flap technique, an initial horizontal incision will
be made towards the palatal/lingual side and two vertical incision will be given 1–2 mm from the teeth adjacent to the edentulous space joining the horizontal cut. The flap of the epithelium along with connective tissue will be reflected towards the buccal side. Then flap will be de-epithelized and connective tissue pedicle will be rolled beneath the buccal mucosa to augment the soft tissue. Implant osteotomy site
preparation will be done using conventional implant drills to
receive the predetermined implant and healing cap will be placed along with sutures.
In Modified connective punch technique the incision will be
made with a motor driven circular tissue punch. The
connective punch will first be deepithelized and than detached. After that a full-split dissection will be performed,to create a deep pouch, on the vestibular side beyond the mucogingival junction. This will be the recipient side for connective tissue graft. The punch will be inserted in deep portion of the pouch and left in this position. Implant osteotomy site preparation will be done using conventional implant drills to receive the predetermined implant and
healing cap will be placed.
|
| Comparator Agent |
Dental Implant Placement by Mid-Crestal flap |
A mid-crestal incision will be made than crevicular incision
upto one tooth on either side of edentulous area will be
given. A full thickness mucoperiosteal flap will be reflected. Implant osteotomy site preparation will be done using conventional implant drills to receive the predetermined implant and a healing cap will be placed and flap will be sutured. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Systemically healthy patients requiring and opting Dental Implants for replacement of missing teeth in maxilla and mandible.
2) Age range: 20-75 years
3) Good oral hygiene and periodontal status
4) Adequate amount of bone volume at implant site allowing to perform the surgery. |
|
| ExclusionCriteria |
| Details |
1) Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2) Pregnant or lactating females.
3) H/o radiotherapy, smokers, parafunctional habits, acute and chronic infection.
4) Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare Keratinized tissue width, Keratinized tissue thickness, Tip of healing cap-gingival margin distance
, Radiographic Crestal bone loss.
|
1. T0- On day of Dental Implant Placement
2. T1- at 3 months after Dental Implant Placement
3.T2- at 6 months after Dental Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction Index |
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)
|
01/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Flap designs for dental implant surgery have been modified and various atraumatic techniques are introduced for the benefit of patients. The conventional approach to implant surgery involves flap elevation, which improves control of placement angulation but resulted in increased soft tissue , bone loss, postoperative pain and delayed recovert due to increased surgical trauma. So to overcome this issues modified flapless and buccal roll technique has been introduced, so aim of this study is evaluation and comparison of soft and hard tissues in midcrestal flap, buccal roll flap and modified punch technique in single stage dental implants. |