| CTRI Number |
CTRI/2025/06/088972 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“Comparison of traditional Flap and novel Flapless approach for Single stage dental Implants.”
|
|
Scientific Title of Study
|
Comparative assessment of hard and soft tissue changes in flap and minimally invasive flapless approach in bone-level single-stage implant: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishwa Amin |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
25 D Jay Gayatri Nagar Near Amit Nagar
VIP Road
Vadodara
390022
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
8141804384 |
| Fax |
|
| Email |
vishwaamin9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital and ORI |
| Address |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Vishwa Amin
Department of periodontics and implantology
Manubhai Patel dental college and hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge munjmahuda
Vadodara
Gujarat
390011
India |
|
|
Primary Sponsor
|
| Name |
DR VISHWA AMIN |
| Address |
Department of Periodontics and Implantology
Manubhai Patel Dental
College and Hospital and ORI munjmahuda
vadodara gujarat
390011 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vishwa Amin |
Manubhai Patel Dental College and Hospital and ORI |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT |
08141804384
vishwaamin9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual without systemic disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flap approach |
Novel flap reflection approach is used. |
| Comparator Agent |
Minimally invasive flapless approach |
Minimally invasive flapless approach using round rotatory diamond bur. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Periodontally healthy subjects.
Nonsmokers.
Age over 18 years.
Agreed to follow-up visits for 6 months.
Presence of a minimum of 2 mm of Keratinized Mucosa at the labial/Buccal aspects in the implant zone.
Minimum crestal bone width 5-6mm (buccolingually).
Bone architecture without undercuts and presence of 1 mm of bone buccolingual to the planned position in a favorable prosthetic situation from pre-operative CBCT.
Subjects signed surgical consent forms.
|
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases affecting the healing process.
Uncontrolled or poorly controlled diabetes.
Pregnant and lactating women.
Radiation to the head and neck.
Subjects requiring guided bone regeneration.
Previous implant installation or bone grafting at the Surgical site.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Width of Keratinized Mucosa.
2) Marginal bone loss
|
1) The width of Keratinized Mucosa will be evaluated at baseline, 3 months, and 6 months postoperatively.
2) Marginal bone loss to be assessed: Baseline, 3-month and 6-month post-operatively using RadioVisioGraphy (RVG).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wound healing index.
|
The wound healing index will be evaluated at 1 week, 2 weeks, and 4 weeks post-surgery.
|
Modified plaque index (mPI).
and Modified Sulcus bleeding index |
Modified plaque index (mPI) & Modified Sulcus bleeding index will be evaluated at 1 month, 3 months, and 6 months post-surgery. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
07/07/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To evaluate clinical and radiographic outcomes in flaps and a minimally invasive flapless approach using a single-stage bone-level implant. To examine hard and soft tissue changes in the form of marginal bone loss and the width of keratinized mucosa after 1-month, 3-month, and 6-month follow-up period. |