| CTRI Number |
CTRI/2026/03/107170 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Dental Implants Placed Under the Gums and Implants Left Exposed to Evaluate Healing Gum Health and Bone Support |
|
Scientific Title of Study
|
Comparative evaluation of submerged versus Non submerged dental implants a clinicoradiographic study Randomized controlled clinical 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 |
DrSharanya Hulloli |
| Designation |
1st year MDS student in Periodontology |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences,Rural dental college, Department of Periodontology,room no.404 ,Loni,Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9689313972 |
| Fax |
|
| Email |
sharanyahulloli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmit Mani |
| Designation |
Professor and HOD of Department of Periodontics |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences Department of Periodontology room no. 404,Rural Dental college ,Loni Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9545612345 |
| Fax |
|
| Email |
drmaniamit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShivani Sachdeva |
| Designation |
Professor |
| Affiliation |
Pravara institute of medical sciences |
| Address |
Pravara institute of medical sciences Loni Department of Periodontology room no. 404, Rural Dental college Loni Ahmadnagar 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9730548805 |
| Fax |
|
| Email |
dr.shivani19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences Loni Rural Dental College Ahmednagar Maharashtra India 413736 |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Rural Dental College Loni 413736 Ahmadnagar,Maharashtra. |
| 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 |
| DrSharanya Hulloli |
Rural Dental College |
Pravara institute of medical sciences Rural dental college Department of periodontology room no 404 Loni Ahmednagar 413736
Ahmadnagar
MAHARASHTRA |
9689313972
sharanyahulloli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PIMS DU LONI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Submerged Dental Implants |
It is one stage surgical technique.Gingival former will be placed immediately after the implant placement.clinical and radiographic parameters will be evaluated at baseline and at 3 months. |
| Comparator Agent |
Submerged Dental Implants |
It is two stage surgical technique.Cover screw will be placed after implant placement.Gingival former will be placed after 3 months and clinicoradiographic parameters will be evaluated at baseline and at 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient giving informed consent
2. Non restorable maxillary and mandibular posterior teeth with intact adjacent teeth.
3. Sufficient apical bone of 3 to 5mm to anchor the implant with minimum primary stability.
4. minimum of 3mm of attached keratinized buccal mucosa.
5. Sufficient prosthetic space for placement of drfinite restoration. |
|
| ExclusionCriteria |
| Details |
1.Patients who are alcoholic or drug abusers.
2.Smokers.
3.Patients with acute periapical infections.
4.Patients had or undergoing radiotherapy to the head and neck region due to malignancy.
5.Patient with known systemic disease or any blood borne disease.
6.Bruxer patients or having TMJ dysfunction.
7.Intake of drugs affecting bone metabolism.
8.Uncontrolled diabetic patients.
9. Patients with D4 bone quality.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare peri implant probing depth in submerged and non submerged dental implants clinically at baseline and after 3 months.
2.To evaluate and compare the width of attached gingiva in submerged and non submerged dental implants clinically at baseline and after 3 months.
3.To evaluate and compare the mucosal thickness in submerged and non submerged dental implants clinically at baseline and after 3 months.
4.To evaluate and compare marginal bone levels and crestal bone loss in submerged and non submerged dental implants radiographically at baseline and after 3 months.
5.To evaluate post operative pain and post operative complications in submerged and non submerged dental implants .
|
At Baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate cumulative time for surgery required in submerged and non submerged dental implants.
2.No.of surgery required in placing submerged and non submerged dental implants. |
At Baseline and after 3 months. |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
12/04/2026 |
| 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)
|
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
|
This randomized controlled clinical trial aims to comparatively evaluate submerged and non-submerged dental implants using clinical and radiographic parameters. A total of 14 patients with bilateral missing posterior teeth (28 implant sites) will be included in the study conducted at the Department of Periodontology, Rural Dental College, Loni. Each patient will receive both implant protocols using a split-mouth design with random allocation by lottery method.
In the test group, non-submerged implants with immediate gingival former placement will be performed, while in the control group, submerged implants with cover screw placement will be done. Clinical parameters including peri-implant probing depth, mucosal thickness, and width of attached gingiva will be assessed at baseline and 3 months postoperatively. Radiographic evaluation of marginal bone levels and crestal bone loss will be performed using standardized intraoral periapical radiographs. Secondary outcomes such as post-operative pain (VAS score), post-operative complications, cumulative surgical time, and number of surgical interventions will also be recorded.
The study duration will be 24 months following ethical approval. The objective is to determine whether non-submerged implants provide comparable or superior clinical, radiographic, and patient-related outcomes compared to submerged implants. |