| CTRI Number |
CTRI/2023/08/056500 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
12/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare & evaluate guava leaf powder in the treatment of periodontal osseous defects |
|
Scientific Title of Study
|
Comparative evaluation of Psidium guajava leaf powder with Injectable Platelet Rich Fibrin & Demineralized Freeze-dried Bone Allograft with Injectable Platelet Rich Fibrin in the treatment of periodontal intrabony osseous defects: A Clinico-Radigraphic 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 |
VSPM Dental College and Research Centre Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry VSPM Dental College and Research Centre Digdoh hills Hingna Road 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 |
VSPM Dental College and Research Centre Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry VSPM Dental College and Research Centre Digdoh hills Hingna Road 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 |
VSPM Dental College and Research Centre Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry VSPM Dental College and Research Centre Digdoh hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM Dental college and Research Centre Nagpur |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
None |
| 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 |
VSPM Dental College and Research Centre |
104 Department of Periodontics and Implant Dentistry VSPM Dental College and Research Centre Digdoh hills Hingna road Nagpur
Nagpur
MAHARASHTRA |
9011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
iPRF plus Psidium guajava leaf powder |
herbal powder with bone regenerative capacity
Assessed at baseline, 3 and 6 months |
| Comparator Agent |
PRF plus DFDBA |
conventional bone graft material 3months, 6Months |
|
|
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, allergies 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 (PI>1.5) will be excluded from the study.
5) In addition, tooth with caries, mobility > grade II will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth(PPD), Clinical Attachment Level
(CAL) |
baseline 3 & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Index (PI), Gingival Index (GI) |
baseline 3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/08/2023 |
| 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="0"
Months="9"
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 current study evaluated and compared the efficacy of Psidium guajava leaf powder plus iPRF versus DFDBA plus iPRF in the treatment of periodontal intrabony osseous defects by CBCT. The following clinical parameters will be evaluated: 1. Plaque index (Silness and Loe) 2. Gingival index (Loe and Silness) 3. Probing pocket depth (PPD) 4. Clinical attachment loss (CAL) Assessment will be done at baseline, 3 and 6 months. For a sample size of 28 sites, 14 sites per group. |