| CTRI Number |
CTRI/2018/04/013015 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
30/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effect of combination of 1% ornidazole and 0.25% chlorhexidine gluconate (Ornigreat gel) and aloevera gel in the treatment of patients with gum diseases |
|
Scientific Title of Study
|
To compare and evaluation the efficacy of combination of 1% Ornidazole and 0.25% Chlorhexidine gluconate (Ornigreat gel)and Aloe vera gel in the treatment of Chronic Periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bukkapatnam V Subbareddy |
| Designation |
postgraduate student |
| Affiliation |
Vishnu dental college |
| Address |
Room No: 7,
Dept.of periodontics
Block no 2
Vishnu dental college
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9581712193 |
| Fax |
08816250894 |
| Email |
subbareddybv1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu dental college |
| Address |
Room No: 7,
Dept.of periodontics
Block no 2
Vishnu dental college
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
08816250894 |
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu dental college |
| Address |
Room No: 7,
Dept.of periodontics
Block no 2
Vishnu dental college
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
08816250894 |
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vishnu college of Pharmacy,
Vishupur,
Bhimavaram-534202,
West godavari district,
Andhra Pradesh |
| Vishnu dental college,
VIshnupur,
Bhimavaram-534202,
West godavari district,
Andhra pradesh
|
|
|
Primary Sponsor
|
| Name |
B V Subbareddy |
| Address |
Post graduate student,
room no.7
Dept of periodontics
Vishnu dental college
Bhimavaram-534202
West Godavari
Andhra Pradesh |
| 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 B V Subbareddy |
Vishnu dental college |
Room no 7
Dept of periodontics
Block no 2
Bhimavaram
534202
West Godavari
ANDHRA PRADESH |
9581712193
08816250894
subbareddybv1989@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| vishnu dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% Ornigreat gel with composition of 0.25% w/w Chlorhexidine gluconate and 1% w/w Ornidazole |
localised delivery of 1% Ornigreat gel into the periodontal pocket after the nonsurgical periodontal therapy. |
| Intervention |
Aloe vera gel |
Localised delivery of Aloe vera gel taken from aloe vera plant in to the periodontal pocket at the time nonsurgical periodontal therapy |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. patients diagnosed with mild to moderate periodontitis according to AAP guidelines 1999
2. minimum of 20 teeth in mouth
3. patients who have not received periodontal treatment for past 6 months to 1 year |
|
| ExclusionCriteria |
| Details |
1. patients with uncontrolled systemic diseases
2. patients with aggressive periodontitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing depth |
baseline and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. plaque index
2. gingival index
3. bleeding index
4. clinical attachment level |
Baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/06/2017 |
| Date of Study Completion (India) |
27/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Penmetsa GS, Subbareddy B,Mopidevi A, Arunbhupathi P, Baipalli V, Pitta S. Comparing the effect of combination of 1% ornidazole and 0.25%chlorhexidine gluconate (ornigreat) gel and aloevera gel in the treatment of chronic periodontitis: A randomised, single-blind, splitmouth study. Contemp Clin Dent 2019;10:226-31 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is conducting to evaluate the efficacy of subgingivally delivered ornigreatTM gel and aloe vera gel in the treatment of chronic periodontitis by measuring the following parameters. Patients will be evaluated at baseline and 4 weeks after treatment, primary outcome measures are the reduction in probing depth after local drug delivery at treated sites, secondary outcome measures are plaque index, gingival index, probing depth, clinical attachment level. |