| CTRI Number |
CTRI/2026/03/107082 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how gum tissue heals around dental implants using two different types of healing caps. |
|
Scientific Title of Study
|
Comparative evaluation of peri-implant soft tissue response to graphene reinforced PMMA and PEEK customized healing abutments: A randomized 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 |
Dr Damodar Shanbhag |
| Designation |
PG Student |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences. |
| Address |
Department of Prosthodontics, Crown and Bridge Dentistry,
Rural Dental College,
Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
919619629732 |
| Fax |
|
| Email |
damunine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Saraf |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences. |
| Address |
Department of Prosthodontics, Crown and Bridge Dentistry,
Rural Dental College,
Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
91819412627 |
| Fax |
|
| Email |
drveenasaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Saraf |
| Designation |
Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences. |
| Address |
Department of Prosthodontics, Crown and Bridge Dentistry,
Rural Dental College,
Pravara Institute of Medical Sciences,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
91819412627 |
| Fax |
|
| Email |
drveenasaraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| 401, Department of Prosthodontics,Crown and Bridge Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni, Ahmadnagar, Maharashtra 413736, India |
|
|
Primary Sponsor
|
| Name |
Dr Damodar Shnabhag |
| Address |
401, Department of Prosthodontics,Crown and Bridge Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni, Ahmadnagar, Maharashtra 413736, India |
| 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 Damodar Shanbhag |
Rural Dental College |
Department of Prosthodontics,Crown and Bridge Dentistry,
Pravara Institute of Medical Sciences,Loni 413736
Ahmadnagar
MAHARASHTRA |
919619629732
damunine@gamil.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 |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graphene reinforced PMMA customized healing abutment |
Graphene-reinforced PMMA customized healing abutments have potential advantages in peri-implant soft tissue healing, antimicrobial properties, and mechanical strength compared to conventional materials. Graphene incorporation may enhance surface characteristics, reduce biofilm adhesion, and improve tissue response during the healing phase of implant therapy. |
| Comparator Agent |
PEEK customized healing abutment |
PEEK customized healing abutments have potential advantages in peri-implant soft tissue healing due to their favorable elastic modulus and bioinert properties. The material may provide improved tissue adaptation and reduced inflammatory response during the healing phase, which warrants clinical evaluation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients with the age 18 years and above.
ii. Partially Edentulous cases indicated for implant
iii. Patient with informed consent willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
i. Patient not indicated for dental implant procedure like
a. Patients on anticoagulant, corticosteroid, fibrinolytic and anti-platelet therapy,
b. Patients with bleeding disorders
c. Patients with debilitating diseases.
ii. Patients requiring immediate implant placement following tooth extraction
iii. Patients in whom an immediate transmucosal healing abutment was planned to be placed at the time of implant insertion
iv. Patients receiving medications that interfere with bone metabolism or soft tissue healing
v. Presence of active infection or acute inflammatory pathology at the proposed implant site.
vi. Sites requiring extensive guided bone regeneration or major augmentation procedures at the time of implant placement.
vii. Pregnant or lactating women,
viii. Patients with a history of smoking or tobacco use
ix. Patients unable or unwilling to comply with the study protocol, including scheduled follow-up visits, oral hygiene instructions, or postoperative care requirements.
|
|
|
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 |
| Evaluation and comparison of soft tissue parameters under bleeding on probing (BOP), peri-implant mucosal thickeness,plaque accumulation, probing depth, horizontal tissue linear alterations,vertical tissue linear alterations among graphene reinforced PMMA and PEEK customized healing abutments. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of soft tissue irritation or soreness |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
15/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2026 |
| 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 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
|
This randomized clinical trial aims to evaluate and compare the peri-implant soft tissue response to graphene-reinforced PMMA and PEEK customized healing abutments placed during second-stage implant surgery. A total of 22 patients undergoing implant therapy will be randomly allocated into two groups. Customized healing abutments will be digitally designed and fabricated using CAD/CAM technology. Peri-implant soft tissue parameters including bleeding on probing, plaque accumulation, probing depth, mucosal thickness, horizontal and vertical soft tissue dimensions, and patient-reported discomfort will be assessed at baseline and 3 weeks after placement. The study intends to generate clinical evidence regarding the soft tissue behavior of graphene-reinforced PMMA compared to PEEK to support material selection in implant prosthodontics. |