| CTRI Number |
CTRI/2025/11/097248 [Registered on: 11/11/2025] 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 Trial |
|
Public Title of Study
|
Soft tissue attachment and bone loss around Implant placed in different gingival thickness with or without graft placement. |
|
Scientific Title of Study
|
Evaluation of soft tissue augmentation and crestal bone loss simultaneous to Implant placement in different mucosal biotypes with or without connective tissue graft: Clinico- radiographic study |
| 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 Laxmi Mallikarjun Boragi |
| Designation |
Post graduate student |
| Affiliation |
P.M. Nadagouda Memorial Dental College and Hospital |
| Address |
Dept. of Periodontology and implantology, Room No. 4, P.M. Nadagouda memorial Dental college and hospital, Navanagar, Bagalkote 587103
Dept. of Periodontology and implantology, Room No. 4, P.M. Nadagouda memorial Dental college and hospital, Navanagar, Bagalkote 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
6362423019 |
| Fax |
|
| Email |
laxmiboragi1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati C Koregol |
| Designation |
Professor |
| Affiliation |
P.M. Nadagouda Memorial Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Room No.4,P.M. Nadagouda Memorial Dental College and Hospital Navanagar Bagalkote 587103
Department of Periodontology and Implantology, Room No.4,P.M. Nadagouda Memorial Dental College and Hospital Navanagar Bagalkote 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
9448157194 |
| Fax |
|
| Email |
aratiperio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Mallikarjun Boragi |
| Designation |
Post graduate student |
| Affiliation |
P.M. Nadagouda Memorial Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Room No.4,P.M. Nadagouda Memorial Dental College and Hospital Navanagar Bagalkote 587103
Department of Periodontology and Implantology, Room No.4,P.M. Nadagouda Memorial Dental College and Hospital Navanagar Bagalkote 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
6362423019 |
| Fax |
|
| Email |
laxmiboragi1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.M. Nadagouda Memorial Dental College and Hospital, Department of Periodontology and Implantology, Room No. 4, Navanagar Bagalkote 587103 |
|
|
Primary Sponsor
|
| Name |
Dr Laxmi Mallikarjun Boragi |
| Address |
P.M. Nadagouda Memorial Dental College and Hospital, Department of Periodontology and Implantology, Room No 4, Navanagar Bagalkote 587103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| INDIAN SOCIETY OF PERIODONTOLOGY |
Dr. Ashish Jain, Secretary ISP, 721, Phase 3B-1, Mohali, SAS Nagar. 160060. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Laxmi Mallikarjun Boragi |
P.M. Nadagouda Memorial Dental College and Hospital |
Department of periodontology and Implantology , Room No. 04 , Navanagar, Bagalkote, Karnataka, 587103
Bagalkot
KARNATAKA |
6362423019
laxmiboragi1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee P.M.N.M. Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dental Titanium implant |
Dental titanium implants will be placed in the edentulous space of the jaw with different mucosal biotypes with connective tissue graft in thin mucosal biotype and without graft in thick biotype |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
22.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1. Subjects who are willing to participate in the study and given written consent for the same.
2. Subjects in age group of 22 years to 60 years, both males and females who are systemically healthy.
3. Completely healed edentulous ridges (at least 3 months after tooth extraction), periodontally sound neighbouring teeth, having no contraindications to the implantation procedure will be motivated for implant treatment.
4. No bone augmentation procedures before and during implant placement.
5. No medical contraindication for implant surgery.
6. Patients with no systemic diseases and bone metabolic disorders are included.
7. Patients with adequate interarch space.
8. Good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases that could influence periodontal conditions or history of periodontitis or peri-implantitis treatment.
2. Poor oral hygiene, smoking, subjects consuming tobacco in any form, alcoholic person, use of drugs affecting bone remodeling.
3. Presence of systemic disease affecting bone loss, uncontrolled diabetes.
4. Immediate implant loading and fresh socket implant.
5. Alveolar ridges with bone defects at implantation sites.
6. General contraindications for implant surgery (e.g., Psychiatric problems, pregnant or lactating females) or presence of life-threatening conditions like cardiac complications.
7. Patient with the history of radiotherapy and chemotherapy.
8. Supraerupted opposing tooth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Less crestal bone loss around implants placed in thin mucosal biotype with connective tissue graft |
Mucosal biotype will be assessed at baseline before implant placement and 3 months, 6 months and 9 months by transgingival probing in thin mucosal biotype post implant placement with connective tissue graft and crestal bone level will be assessed before implant placement, immediately post implant placement and 9 months using CBCT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| More crestal bone loss around implants placed in thick mucosal biotype without connective tissue graft |
Mucosal biotype will be assessed at baseline before implant placement and 3 months, 6 months and 9 months by transgingival probing in thick mucosal biotype post implant placement without connective tissue graft and crestal bone level will be assessed before implant placement, immediately post implant placement and 9 months using CBCT |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
01/12/2025 |
| 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
|
i) Rationale: Dental implants are reliable solution for tooth loss, but soft tissue regression, alveolar bone resorption can impact outcome and aesthetics. Research by Berglundh et al. concludes thinner tissues lead to more significant bone loss, while thicker tissues help preserve bone levels. To assure greatest therapeutic benefit, both soft and hard tissue augmentation techniques are used, with autogenous connective tissue grafts (CTG) being the gold standard for soft tissue enhancement due to their biocompatibility and regenerative potential. This study aims to evaluate the effect of CTG on soft tissue augmentation and crestal bone levels[CBL] in different mucosal biotypes during implant placement.
ii) Novelty: Implant placement along with CTG in thin mucosal biotype by Egreja et al 2012 and without in thick biotype and soft tissue augmentation will be assessed. CBL will be assessed in both mucosal biotypes using CBCT - CS Imaging [care stream imaging] version 8.0.
ii) Objectives: · Soft tissue augmentation is assessed in thin biotype with CTG and without in thick biotype simultaneous to implant placement at baseline, 3, 6, and 9 months. · To evaluate and compare the CBL around implants placed in different mucosal biotype at baseline, immediately after placement and 9 months. iv) Methods: Mucosal thickness is assessed via transgingival probing by Dimitrios Kloukas et al 2021 using endodontic spreader and endodontic gauge. Soft tissue augmentation is evaluated with CTG in thin and without in thick. CBL is assessed via CBCT. V) Expected outcome: Minimal soft tissue regression and CBL in thin tissue with CTG as compared to thick tissue alone. |