| CTRI Number |
CTRI/2026/01/102434 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Bone Healing Around Dental Implants After Application of Emdogain in Adult Patients |
|
Scientific Title of Study
|
Effect of Emdogain On Dental Implant Osseointegration: A 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 |
Sushrima Dey |
| Designation |
Post graduate Trainee |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences. KIIT Deemed to be University. Campus 5. Patia, Bhubaneswar 751024
Khordha
ORISSA
751024
India |
| Phone |
7278473139 |
| Fax |
|
| Email |
sushrima.31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohammad Jalaluddin |
| Designation |
Professor and head |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences. KIIT Deemed to be University. Campus 5. Patia, Bhubaneswar 751024
Khordha
ORISSA
751024
India |
| Phone |
9338131843 |
| Fax |
|
| Email |
drjalal1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushrima Dey |
| Designation |
Post graduate Trainee |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Kalinga Institute of Dental Sciences. KIIT Deemed to be University. Campus 5. Patia, Bhubaneswar 751024
Khordha
ORISSA
751024
India |
| Phone |
7278473139 |
| Fax |
|
| Email |
sushrima.31@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sushrima Dey |
| Address |
Kalinga Institute Dental Sciences. KIIT Deemed to be University. Campus 5. Patia, Bhubaneswar 751024 |
| 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 Sushrima Dey |
Kalinga Institute Dental Sciences |
Department of Periodontology, Kalinga Institute of Dental Sciences, KIIT deemed to be University. Campus 5, Patia. Bhubaneswar 751024
Khordha
ORISSA |
7278473139
sushrima.31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Dental implant Placement |
Local anesthesia with adrenaline will be administered to the patients and full-thickness mucoperiosteal flap to be reflected. The implant length selection will be done according to the bone availability Implant osteotomy sites to be prepared with sequential drilling under copious irrigation. The drilling protocols will follow those recommended by the manufacturers. Dental implant will be done followed by placement of a coverscrew. Flap closure will be achieved using sutures to protect the implant site. |
| Intervention |
Dental implant placement coated with Enamel Matrix Derivative |
Local anesthesia with adrenaline will be administered to the patients and full-thickness mucoperiosteal flap to be reflected.
The implant length selection will be done according to the bone availability
Implant osteotomy sites to be prepared with sequential drilling under copious irrigation. The drilling protocols will follow those recommended by the manufacturers.
A topical application of Emdogain on the implant will be done, followed by the placement of implant and coverscrew.
Flap closure will be achieved using sutures to protect the implant site. Follow up will be done till 6months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients after PSR screening code 0, 1, 2.
Patients without any systemic disease.
Patients with enough mesiodistal and interocclusal space or crown height space of 8-12mm.
Patients with D2-D3 bone density. |
|
| ExclusionCriteria |
| Details |
Patients with medical history that can contradict dental treatment placement including uncontrolled diabetes.
Patients with recent history of heart surgery, heart attack or stroke within 6months, history of radiotherapy/ chemotherapy for malignancy over past 5 years.
Patients on long-term steroid, anticoagulant or bisphosphonate therapy.
Pregnant, lactating women.
Patients with history of allergy.
Patients with inadequate oral history with plaque score more than 3
Chronic smokers.
Patient with parafunctional habits, temporomandibular joint disease.
Presence or sign of active infection and pus formation in implant site.
Patients undergoing orthodontic treatment.
Patient who is not willing to participate will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peri implant probing depth (in mm)
Gingival biotype
Wound healing index.
Bone density
Crestal bone loss |
Peri implant probing depth (in mm)
Gingival biotype
Wound healing index
Bone density
Crestal bone loss will assessed at Baseline, 3months and 6months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oral hygiene Index
Gingival index |
Baseline, 3months, 6months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
09/02/2026 |
| 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 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 study aims to compare the clinical, radiographic, and osseointegration outcomes between Emdogain coated implants and conventional titanium implants over a 6-month follow-up period, thereby evaluating the potential role of Emdogain in enhancing peri-implant tissue healing and implant integration. This randomized, controlled clinical study is designed to evaluate the effect of Enamel Matrix Derivative (Emdogain) applied to dental implant surfaces on peri-implant soft and hard tissue outcomes, as well as on early osseointegration. The study will be conducted on 20 systemically healthy subjects (18–65 years) reporting to the OPD of the Department of Periodontics & Oral Implantology, KIDS, KIIT Deemed to be University, Bhubaneswar, who are indicated for dental implant placement. A total of 26 implant sites will be randomly allocated into two equal groups: Group A, receiving implants placed by the conventional protocol, and Group B, receiving implants coated with Emdogain prior to placement. Standardized pre-surgical periodontal evaluation, oral prophylaxis, and CBCT assessment will be performed for all participants. Implants will be placed under local anesthesia following manufacturer-recommended drilling protocols. In Group B, Emdogain will be topically applied to the implant surface before insertion. Clinical parameters including periodontal probing depth, gingival biotype, and wound healing index will be assessed, while radiographic evaluation of bone density and crestal bone levels will be performed. Assessments will be recorded at baseline (immediate post-implant placement), 3 months, and 6 months postoperatively. |