| CTRI Number |
CTRI/2024/08/072016 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing tiny particles of hydroxyapatite alone and with herbal gel for treating bony defects using clinical and radiographic methods.
|
|
Scientific Title of Study
|
Comparative evaluation of hydroxyapatite nanoparticles with and without herbal gel in the treatment of periodontal intrabony osseous defects: 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 |
Dr. Surekha Rathod |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur. |
| Address |
Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. SUREKHA RATHOD |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur. |
| Address |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surekha Rathod |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur. |
| Address |
Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre, Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Nagpur-440019, India. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [None] |
|
|
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 Surekha Rathod |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur:440019 |
104, Department of Periodontics and Implant Dentistry.
Nagpur
MAHARASHTRA |
9011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novel Composite graft |
Pectin, bromelain, hydroxyapatite nanoparticles, propyl paraben, palaxomer 407 and deionized water. |
| Comparator Agent |
Standard control |
Hydroxyapatite nanaoparticles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with stage III periodontitis assessed by probing pocket depth (PPD) ≥ 6mm, interdental clinical attachment loss (CAL) ≥ 5mm.
2) Patients with two or three wall intraosseous defects in either maxillary or mandibular arch or interarch.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of systemic diseases, allergy or drug usage.
2) Patients who have undergone periodontal treatment in previous 6 months.
3) Pregnant or lactating women.
4) Smokers, tobacco chewers and patients with poor oral hygiene index will be excluded from the study.
5) In addition, tooth with caries, mobility greater than grade II will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of hydroxyapatite nanoparticles with and without herbal gel in the treatment of periodontal intrabony osseous defects, clinically and radiographically by CBCT. |
Baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intraosseous bony defects when treated with herbal gel with hydroxyapatite nanoparticles at baseline, 3 months and 6 months post operatively.
2) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intraosseous bony defects when treated with hydroxyapatite nanoparticles at baseline, 3 months and 6 months postoperatively.
3) To assess radiographic bone fill obtained in intraosseous bony defects when treated herbal gel with hydroxyapatite nanoparticles at baseline and 6 months post operatively by Cone Beam Computed Tomography (CBCT).
4) To assess radiographic bone fill obtained in intraosseous bony defects when treated with hydroxyapatite nanoparticles at baseline and 6 months post operatively by Cone Beam Computed Tomography (CBCT).
|
Baseline, 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Comparative evaluation of hydroxyapatite nanoparticles with and without herbal gel in the treatment of periodontal intrabony osseous defects: A Clinico-Radiographic Study Periodontitis is a polymicrobial disease where the inflammatory process results in progressive tissue destruction. Destructive periodontitis caused by bacterial plaque involves resorption of alveolar bone supporting the teeth. The ultimate goal of periodontal therapy is to arrest the disease progression and to promote the regeneration of the lost tissues. A synthetic nanocrystalline hydroxyapatite (NHA) paste, containing 65% water and 35% nanostructured apatite particles has been introduced for augmentation procedures in osseous defects. Advantages of this material are the close contact with surrounding tissues, quick resorption characteristics, and the large number of molecules on the surface. There are many natural or herbal powders in research for their benefits over synthetic materials. This high popularity in applying complementary and alternative medicine can be due to its advantages such as widespread availability, no or fewer side effects, moderate efficacy, and low cost as compared with synthetic drugs. Kepok banana peel (Musa paradisiaca linn. Kepok) contains active ingredients such as Âavonoids, tannins, saponins, and gallocatechinese. These active ingredients possess antioxidant, antibacterial, anti-inflammatory and analgesic activities. Bromelain, an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties. To our knowledge the current randomized clinical trial is the first to explore the adjunctive effect of combining herbal gel with hydroxyapatite nanoparticles in the surgical treatment of intraosseous bony defects by Cone Beam Computed Tomography (CBCT). So, this study is designed to evaluate and compare the efficacy of hydroxyapatite nanoparticles with and without herbal gel in the treatment of periodontal intrabony osseous defects by CBCT.
|