| CTRI Number |
CTRI/2024/08/072688 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
uSE of honey bee wax gel and dental laser in treatment of gum diseases |
|
Scientific Title of Study
|
Comparative evaluation of propolis gel and laser disinfection in non-surgical treatment of periodontitis- A Randomized clinical 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 |
Shaik Ayesha Nowreen |
| Designation |
post graduate student |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no : 5
Department of periodontology
Narayana dental college and hospital
Chintareddypalem
Nellore
524003
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9182063357 |
| Fax |
|
| Email |
ayeshashaik2399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUKRUTHA B |
| Designation |
Reader |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no : 5
Department of periodontology
Narayana dental college and hospital
Chintareddypalem
Nellore
524003
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9581440936 |
| Fax |
|
| Email |
drsukruthareddy9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUKRUTHA B |
| Designation |
Reader |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no : 5
Department of periodontology
Narayana dental college and hospital
Chintareddypalem
Nellore
524003
Andhra Pradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9581440936 |
| Fax |
|
| Email |
drsukruthareddy9@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROOM NO : 5
Department of periodontology
Narayana dental college and hospital
chintareddypalem
Nellore
524003
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Shaik Ayesha Nowreen |
| Address |
Department of periodontology
room no 5
narayana dental college and hospital
chintareddypalem
nellore
524003
Andhra pradesh |
| Type of Sponsor |
Other [private dental college] |
|
|
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 |
| Shaik Ayesha Nowreen |
Narayana dental college and hospital |
department of periodontology
Narayana dental college and hospital
room no 5
Chintareddypalem
Nellore
524003
Andhra Pradesh
Nellore
ANDHRA PRADESH |
9182063357
ayeshashaik2399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE NARAYANA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
| Patients |
, (1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of propolis gel and laser disinfection in non-surgical treatment of periodontitis - A RANDOMIZED CLINICAL TRIAL |
In Group 1- Scaling and root planing will be done |
| Comparator Agent |
Comparative evaluation of propolis gel and laser disinfection in non-surgical treatment of periodontitis - A RANDOMIZED CLINICAL TRIAL |
In group II-70% propolis extract gel will be placed once after scaling and root planing as local drug delivery in periodontal pockets.
|
| Intervention |
comparing the efficacy of propolis gel and laser disinfection in periodontitis patients. |
In Group III-After Scaling and root planing Diode laser with 980nm wavelength will be used in periodontal pockets |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients both male and female with age of 18 to 60 yrs.
Patients with presence of minimum 20 teeth.
Patients with pocket depth of ≥ 5mm.
Patients who are non-smokers.
Patients who are co-operative and able to attend the hospital for regular follow up.
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating female.
Patients having any history of systemic disease.
Patients having history of any local / systemic antimicrobial and anti-inflammatory therapy for last 3 months.
Use of tobacco in any form.
Patients who are alcoholic
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in probing pocket depths |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in plaque index, gingival index |
Baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
12/09/2024 |
| 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="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
|
The aim of the study is to evaluate the clinical efficacy of propolis gel as an adjunct to non-surgical periodontal therapy and laser therapy in patients with periodontitis using clinical parameters like probing pocket depth, clinical attachment level, plaque index, bleeding on probing and gingival index will be recorded.
patients were randomly divided into three groups. Group I: Scaling and Root planning [SRP] Group II: Scaling and Root planning [SRP] + Laser Disinfection Group III: Scaling and Root planning [SRP] + Propolis gel
patients will be recalled for follow-up after 3 months for evaluating the clinical parameters. |