| CTRI Number |
CTRI/2025/12/098367 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the bone forming capacity of denosumab and liraglutide with Gelatin sponge in periapical lesions |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF DENOSUMAB+GELATIN SPONGE,
LIRAGLUTIDE+GELATIN SPONGE AND GELATIN SPONGE ON HEALING
OF PERIAPICAL LESIONS USING CONE BEAM COMPUTED TOMOGRAPHY (CBCT) - AN IN VIVO 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 |
Kothai abirami T |
| Designation |
PG student |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Chennai
Esplanade, George Town, Chennai Tamil Nadu 600003 India
Chennai
TAMIL NADU
600003
India |
| Phone |
9789822024 |
| Fax |
|
| Email |
abiraminambi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Kavitha |
| Designation |
Professor and HOD |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Chennai
Esplanade, George Town, Chennai Tamil Nadu 600003 India
Chennai
TAMIL NADU
600003
India |
| Phone |
9841161131 |
| Fax |
|
| Email |
kavithaendo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kothai abirami T |
| Designation |
PG student |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Chennai
Esplanade, George Town, Chennai Tamil Nadu 600003 India
Chennai
TAMIL NADU
600003
India |
| Phone |
9789822024 |
| Fax |
|
| Email |
abiraminambi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tamil Nadu Government Dental College and Hospital,Esplanade, George Town, Chennai Tamil Nadu 600003 India |
|
|
Primary Sponsor
|
| Name |
Kothai abirami T |
| Address |
Tamil Nadu Government Dental College and Hospital, Muthusamy salai, Esplanade George Town,Chennai - 600003 |
| 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 |
| Kothai abirami T |
Tamilnadu government dental college and hospital |
Department of conservative dentistry and Endodontics,
Room No. 1-10, Esplanade, George Town, Chennai Tamil Nadu 600003 India
Chennai
TAMIL NADU |
9789822024
abiraminambi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TamilNadu Government Dental College and Hospital Institutional ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
absorbable gelatin sponge |
commercially available sterile absorbable gelatin sponge (GelSpon) |
| Intervention |
Denosumab |
commercially available denosumab. After placing the denosumab in the bone defect, patient
will be followed for 1 year |
| Intervention |
Liraglutide |
commercially available liraglutide. After placing the liraglutide in the bone defect, patient will be followed for 1 year |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 20-40 years of age from both the gender, Periapical lesions involving maxillary and mandibular incisors of strictly
endodontic
origin, The diameter of the bone defect of 10 -20 mm, Patients willing for voluntary participation & have signed informed consent,
Patients with good oral hygiene, Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
periodontal tooth with poor prognosis, tooth with pathosis with vertical root fracture, patients with bleeding disorders, patients
showing poor oral hygiene maintenance, Patients with use of tobacco or tobacco related products, Pregnant / Lactating patients,
Patients with known systemic diseases, Patients with any known allergies, Patients with any known metabolic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absence of swelling, pain, pus discharge, sinus opening, Mobility, Tenderness to percussion |
1,3,6,9 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone density evaluation of the Periapical region was done after surgery using CBCT |
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2026 |
| 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="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
|
This study is a randomized, double blinded, parallel arm design comparing the effect of denosumab and liraglutide with gelatin sponge on healing of periapical lesions using cone beam computed tomography (CBCT) carried out in Tamil Nadu Government Dental college and Hospital among 30 patients of age group from 20 to 40 years of both gender with periapical lesion size ranging from 10 to 20 mm. The primary outcome should be absence of pain, swelling, pus discharge, sinus opening, tenderness to percussion. The secondary outcome being radiographic evidence of increase in bone density and reduction in size of the lesion at the end of 3, 6, 9 and 12 months. |