| CTRI Number |
CTRI/2025/05/087825 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Healing comfort and bone health in dental implants conventional versus flapless approach |
|
Scientific Title of Study
|
A clinicoradiological evaluation of marginal bone loss tissue changes post operative patients compliance in implants placed with flapless versus conventional surgical technique |
| 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 Sankha Subhra Roy |
| Designation |
Postgraduate |
| Affiliation |
Maharishi markandeshwar college of dental sciences and research |
| Address |
Room no 7 Department of periodontology mullana ambala haryana
Ambala
HARYANA
133203
India |
| Phone |
09310693160 |
| Fax |
|
| Email |
perioprecision23roy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Head and professor |
| Affiliation |
Maharishi markandeshwar college of dental sciences and research |
| Address |
Room no 7 Department of periodontology mullana ambala haryana
Ambala
HARYANA
133203
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankha Subhra Roy |
| Designation |
Postgraduate |
| Affiliation |
Maharishi markandeshwar college of dental sciences and research |
| Address |
Room no 7 Department of periodontology mullana ambala haryana
Ambala
HARYANA
133203
India |
| Phone |
09310693160 |
| Fax |
|
| Email |
perioprecision23roy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi markandeshwar deemed to be university mullana ambala haryana 133203 |
|
|
Primary Sponsor
|
| Name |
Dr Sankha Subhra Roy |
| Address |
Room no 7 Department of periodontology mmcdsr mullana ambala haryana 133203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sankha Subhra Roy |
Maharishi markandeshwar college of dental sciences and research |
Room no 7 Department of periodontology mullana ambala haryana
Ambala
HARYANA |
09310693160
perioprecision23roy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Deemed to be University University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional surgical procedure for implant placement |
For placement of implant conventional surgical flap procedure followed by baseline and 3 months |
| Comparator Agent |
Flapless implant placement |
Flapless implant placement with minimally invasive or tissue punch procedure followed by baseline and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age should be above or equals to 18 years
Patient with partially edentulous area with minimum 5mm bone width and 8 mm bone length in maxilla or mandible
Systematically healthy male and female with co operative ones should be included |
|
| ExclusionCriteria |
| Details |
Patients having any adverse habits like smiking alcohol consumption
Pregnant or lactating woman
Uncontrolled systemic disease
Allergy or hypersensitivity to any product used
Mental or physical disorder
Patients on bisphosphonates any evidence of pathology or active diseases of the implant bed and atrophy requiring bone regeneration in both width and height were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinicoradiological evaluation of marginal bone loss tissue changes post operative patients compliance in implants placed with flapless versus conventional surgical technique |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/06/2025 |
| 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="1"
Months="0"
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
|
The purpose of this study is to compare marginal bone loss and soft tissue changes around implant and pain analgesic and swelling assessments at baseline and 3 months. The null hypothesis is that there is no significant difference between the two treatment modalities. |