| CTRI Number |
CTRI/2024/06/068305 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Subgingival delievery of propolis nanoparticles as an adjunct to scaling and root planing] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of propolis tiny particles placed in gums of patients with gum disease. |
|
Scientific Title of Study
|
Evaluation of clinical efficacy of sub-gingivally delivered Propolis Nanoparticle as an adjunct to non-surgical periodontal therapy in patients with stage 2 and stage 3 periodontitis: a split mouth randomized controlled trial |
| 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 Ankit Desai |
| Designation |
Reader |
| Affiliation |
Terna dental college and Hospital |
| Address |
Department 101, department of periodontology, Plot no.12, Terna Campus Rd, opp. nerul west Railway station, Sector 22,Nerul,Navi Mumbai
Mumbai
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9920789319 |
| Fax |
|
| Email |
desaiankit_2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Desai |
| Designation |
Reader |
| Affiliation |
Terna dental college and Hospital |
| Address |
Department no. 101, Plot no.12, Terna Campus Rd, opp. Nerul west Railway station, Sector 22,Nerul,Navi Mumbai
Mumbai
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9920789319 |
| Fax |
|
| Email |
desaiankit_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shrikhande |
| Designation |
PG student |
| Affiliation |
Terna Dental college and hospital |
| Address |
Department no 101, Plot No. 12, Terna Campus Rd Opp. nerul west Railway station, nerul west , Sector 22, Nerul, Navi Mumbai, Mumbai
MAHARASHTRA
Thane
MAHARASHTRA
400706
India |
| Phone |
8329847052 |
| Fax |
|
| Email |
komal.shrikhande633@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna dental college and hospital |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Dental college |
| Address |
Plot no. 12, Campus Rd,Opp. Nerul west Railway station , Sector 22, Nerul west, Sector 22, Nerul, Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Type of Sponsor |
Other [Private Dental college] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Komal Shrikhande |
TPCTs Terna Dental college |
Department no. 101,
Plot no.12, Terna Campus Rd, Opp nerul west Railway Station, nerul west, Sector 22, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
8329847052
komal.shrikhande633@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental college Institutional review board |
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 |
Propolis nanoparticles solution. |
All patients with stage 2 and stage 3 periodontitis will be treated with scaling and root planing followed by subgingival delivery of propolis nanoparticle solution. Baseline evaluation will be done for plaque index, gingival index, sulcular bleeding index, probing pocket depth, relative attachment loss. Patient will be recalled after 1 month and 3 month for the evaluation of same. |
| Comparator Agent |
Saline |
All patients with stage 2 and stage 3 periodontitis will be treated with scaling and root planing followed by subgingival delivery of saline. Baseline evaluation will be done for plaque index, gingival index, sulcular bleeding index, probing pocket depth, relative attachment loss. Patient will be recalled after 1 month and 3 month for the evaluation of same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female patients with stage 2 or stage 3 periodontitis in at least 2 teeth in contralateral quadrants.2.Age group between 18-60 years with good systemic health.3. Minimum 20 teeth should be present in the mouth of patients.
4.Patients with no history of allergies.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any known systemic
diseases.2.Smokers and alcoholic patients.3 Pregnancy or lactating female patients.4.Patients who have received surgical or nonsurgical periodontal therapy in last 3 months prior to the baseline visit.5.• Patients who have allergic to propolis products.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical efficacy of sub-gingivally delivered Propolis Nanoparticles as an adjunct to non-surgical periodontal therapy in patients with stage 2 and stage 3 periodontitis: a split mouth randomised controlled trial. |
Baseline
one month after local drug delivery
Three month after local drug delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate improvement in plaque index, gingival index, sulcular bleeding index, probing pocket depth and relative attachment loss |
Plaque index, gingival index, sulcular bleeding index, probing pocket depth and relative attachment loss will be evaluated at baseline, one month and three month. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2024 |
| 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="2"
Days="10" |
|
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 is a randomized clinical split mouth study to evaluate the clinical efficacy of sub-gingivally delivered propolis nanoparticles as an adjunct to scaling and root plaing in patients with stage 2 and stage 3 periodontitis. Study design : Group 1 consisting of 25 subjects with stage 2 and stage periodontitis, receiving propolis nanoparticles as a local drug delivery Group 2 consisting of 25 subjects with stage 2 and stage 3 periodontitis, receiving placebo [i.e. saline] as a local drug delivery The clinical parameters [ plaque index, gingival index, relative attachment loss, probing pocket depth , sulcular bleeding index]will be evaluated at baseline, one month and three month period. The data obtained will be entered in Microsoft excel spread sheet and will be further analyzed with the help of SPSS software ( version 17.0, IBM.USA) |