| CTRI Number |
CTRI/2024/05/067068 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of satranidazole and hyaluronic acid gels in addition to scaling and root planing for treatment of stage I and stage II periodontitis |
|
Scientific Title of Study
|
Clinical and microbiological efficacy of 3% satranidazole and 0.8% hyaluronic acid oral insitu gels as an adjunct to scaling and root planing in the treatment of stage 1 and stage 2 periodontitis.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Upputuri venga urekha |
| Designation |
Pg student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no 8,second floor
department of periodontics
sibar institute of dental sciences takellapadu
guntur
andhrapradesh
Guntur ANDHRA PRADESH 522509 India |
| Phone |
08639185751 |
| Fax |
|
| Email |
upputuriurekha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Boyapati ramanarayana |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no 8,second floor
department of periodontics
sibar institute of dental sciences takellapadu
guntur
andhrapradesh
522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Boyapati ramanarayana |
| Designation |
Professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no 8,second floor
department of periodontics
sibar institute of dental sciences takellapadu
guntur
andhrapradesh
522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences and hospital,Takellapadu,Guntur |
|
|
Primary Sponsor
|
| Name |
Upputuri venga urekha |
| Address |
Room no 8,second floor
department of periodontics
sibar institute of dental sciences takellapadu
guntur
andhrapradesh
522509 |
| 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 |
| Upputuri venga urekha |
Sibar institute of dental sciences |
Room no 8,second floor
department of periodontics
sibar institute of dental sciences takellapadu
guntur
andhrapradesh
522509 Guntur ANDHRA PRADESH |
08639185751
upputuriurekha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences |
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 |
| Comparator Agent |
0.8% hyaluronic acid oral insitu gel |
After scaling and root planing oral insitu gels are placed in the periodontal pocket |
| Intervention |
3% satranidazole oral insitu gels |
After scaling and root planing oral insitu gels are placed in the periodontal pocket |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group of 35-55 years of both the gender.
2.Apparently Healthy individuals
3.Subjects with Stage I (Interdental CAL – 1 to 2 mm, radiographic boneloss less than 15% of coronal third, maximum probing depth less than or equal to 4mm) and Stage II periodontitis (Interdental
CAL – 3 to 4mm, radiographic bone loss 15- 33% of coronal third, maximum probing depth less than or equal to 5mm)
4.Subjects who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects using any form of tobacco.
2. History of previous antibiotic therapy within the past 3 months
3. Subjects who has history of drug allergy.
4. Pregnant woman and Lactating mothers.
5. Subjects with Stage III and Stage IV periodontitis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in probing depth ,gain in clinical attachment levels and bacterial count |
Baseline 1 month 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased plaque and gingival score |
Baseline 1 month 3 months |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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 4 |
|
Date of First Enrollment (India)
|
02/06/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Periodontitis is an
oral disease characterized by microbially associated, host mediated
inflammation in the periodontium. In the pathophysiology of periodontitis, the
loss of marginal periodontal ligament fibres is observed, junctional epithelium,
migrates apically which causes biofilm to spread in apical direction along root
surface. Treatment to manage periodontal disease can involve mechanical debridement, which includes scaling and root planing
(SRP) At
the initial visit, a clinical examination will be performed on each patient and
clinical parameters such as plaque index, gingival index, pocket depth and
clinical attachment level will be
recorded. At baseline all the patients will receive
phase I therapy which includes Supragingival scaling and thorough oral hygiene
instructions. Patients will be recalled after one week for Subgingival plaque
sample collection. One week after scaling and root planning, baseline subgingival
plaque sample will be collected using sterile curettes. The collected sample
will be immediately transferred to a transport medium and sent to laboratory
for microbiological analysis
of Porphyromonas gingivalis (Pg), Aggregatibacter
actinomycetemcomitans (Aa) by using multiplex PCR.
In
Group A subgingival scaling and root planing will be done and satranidazole gel is placed. In Group B after subgingival scaling
and root planing hyaluronic acid
gel will be injected into the pocket until the material is detected at the
gingival margin. Then periodontal dressing (coe-pak) will be placed on treated
site to ensure that gel will stay long enough to be effective in the pocket.
After one-week periodontal dressing is removed.
Clinical parameters will be recorded after 1
month and 3 months after treatment and post operative subgingival plaque
samples will be collected from two groups and sent for microbiological analysis
after 3 months.
|