| CTRI Number |
CTRI/2025/04/085196 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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 potential of Hyaluronic acid and bisphosphonate |
|
Scientific Title of Study
|
Comparative evaluation of Hyaluronic acid plus Gelatin sponge, Risedronate plus Gelatin sponge and Gelatin sponge on healing of Periapical lesion using CBCT - An Invivo 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 |
Akshaya S P |
| 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 |
9445436123 |
| Fax |
|
| Email |
akshayasp98@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 |
Akshaya S P |
| 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 |
9445436123 |
| Fax |
|
| Email |
akshayasp98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tamil Nadu Government Dental College and Hospital, Esplanade, George Town, Chennai, Tamil Nadu, India, Chennai - 600003 |
|
|
Primary Sponsor
|
| Name |
Akshaya S P |
| 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 |
| Dr AKSHAYA S P |
Tamilnadu government dental college and hospital |
Department of conservative dentistry and Endodontics, Room No. 1- 10 Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9445436123
akshayasp98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TamilNadu Government Dental College and Hospital Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
absorbable gelatin sponge |
commercially available sterile absorbable gelatin sponge (GelSpon) |
| Intervention |
hyaluronic acid |
commercially available hyaluronic acid gel (gengigel). After placing the hyaluronic gel in the bone defect, patient will be followed for 1 year |
| Intervention |
Risedronate |
Risedronate gel was prepared using the coacervation phase separation method. Accurately, 25 mg of Risedronate was dissolved in 20 ml of ethanol. Further, 3 grams of Carbopol 934 was used to prepare the gel. After Placing the Risedronate gel in the bone defect, the 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="25"
Sample Size from India="25"
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)
|
30/04/2025 |
| 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
|
This study is a randomized, double blinded, parallel arm design comparing the effect of hyaluronic acid and Risedronate gel 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 25 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. |