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CTRI Number  CTRI/2018/03/012278 [Registered on: 01/03/2018] Trial Registered Prospectively
Last Modified On: 25/11/2019
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 ability of a herbal extract along with cleaning of patients with gum dissorders 
Scientific Title of Study   A prospective randomized control trial comparing the efficacy of 3D hydrogel as an adjunct to scaling and root planing in patients with chronic periodontitis-A split mouth clinico-microbial study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnapriya 
Designation  Postgraduate student 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Room no 4 Department of periodontics and Implantology Coorg Institute Of Dental Sciences Kanjithanda Kushalappa campus Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  8277384414  
Fax    
Email  krishnapriya126kp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BS Jagadish Pai 
Designation  Professor and HOD 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Room no 4 Department of periodontics and Implantology Coorg Institute Of Dental Sciences Kanjithanda Kushalappa campus Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  9448163710  
Fax    
Email  bsjpai@cids.edu  
 
Details of Contact Person
Public Query
 
Name  BS Jagadish Pai 
Designation  Professor and HOD 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Room no 4 Department of periodontics and Implantology Coorg Institute Of Dental Sciences Kanjithanda Kushalappa campus Virajpet

Kodagu
KARNATAKA
571218
India 
Phone  9448163710  
Fax    
Email  bsjpai@cids.edu  
 
Source of Monetary or Material Support  
Room no 4 Department of periodontics and Implantology Coorg Institute Of Dental Sciences Kanjithanda Kushalappa campus Virajpet Karnataka-571218  
 
Primary Sponsor  
Name  Krishnapriya 
Address  Room no 4 Department of periodontics and Implantology Coorg Institute Of Dental Sciences Kanjithanda Kushalappa campus Virajpet Karnataka-571218  
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Krishnapriya  Coorg Institute Of Dental Sciences  Room no 4 Department of periodontics and Implantology
Kodagu
KARNATAKA 
8277384414

krishnapriya126kp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic periodontitis patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D Hydrogel  The gel is made of herbal extract of Centella asiatica and the carrier is natural polymer (pectin).  
Comparator Agent  scaling and root planing  mechanical debridement and root planing 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed with chronic periodontitis with pocket depth ≥ 5 mm and having good systemic health.
2) Age of 30 years or older.
3) Minimum sixteen teeth present
4) Test tooth must have a neighbouring teeth (mesial and distal)
 
 
ExclusionCriteria 
Details  1) Any Systemic illness
2) Smoking & patients using other forms of tobacco.
3) Pregnant or lactating women.
4) Systemic antibiotics within the previous 2 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
expecting reduction in probing pocket depth in the region of local delivery of drug.   baseline 6th 10th 14th 18th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in periodontal infection and good oral health  baseline 6th 10th 14th 18th weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   05/03/2018 
Date of Study Completion (India) 19/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/06/2019 
Estimated Duration of Trial   Years="0"
Months="4"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

   

This split- mouth study was conducted in 30 chronic periodontitis patients with persisting deep periodontal pockets of 30-65 years of age at the Department of Periodontics, Coorg Institute of Dental Sciences Virajpet to evaluate the efficacy of scaling and root planing (SRP) and local drug delivery of 3D Hydrogel containing extracts of Centella Asiatica in chronic generalized periodontitis patients. The 3D gel was applied to pocket base of experimental sites by gently inserting the tip of applicator. Over the following 3 weeks the experimental sites received additional sub-gingival gel administration once a week whereas control site received scaling and root planing. Collection of GCF and plaque sample collection were done at 6, 10, 14, 18 weeks (4months after initial treatment) along with clinical parameters and the samples collected were subjected to BAPNA (Nα-Benzoyl-DL-Arginine-p-Nitroanilide assay) to determine trypsin like activity of Red complex micro-organisms.

 Analysis of variance (One Way Repeated ANOVA) was performed as a parametric test to compare the two groups. The clinical parameters were evaluated by using unpaired t-test.

From the results obtained from this study, all the clinical parameters showed a significant reduction from baseline to 6week in both test (SRP+MED) and control group (SRP alone).

The BAPNA values also showed significant reduction from baseline to 6 weeks when in both groups.

The values of clinical parameters showed a statistically non-significant results when both groups were compared.

There was a reverse trend in both values of clinical and BAPNA values after 10th week.

Hence, within the limitations of the study, it can be concluded that, 3 D hydrogel as an adjunct to SRP is an effective treatment method but not superior to SRP. Sub-gingivally delivered gel demonstrated a safety profile with no major common untoward allergic, local or systemic effect.

 
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