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
|
|
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
|
|
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.
|