| CTRI Number |
CTRI/2019/12/022201 [Registered on: 02/12/2019] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check and compare the effect of papaya gel for the treatment of gum conditions |
|
Scientific Title of Study
|
Effect of standardised papaya fruit and leaf extracts as a local drug delivery agent for the treatment of chronic periodontitis: A comparative clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha Jha |
| Designation |
Post-graduate |
| Affiliation |
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center |
| Address |
Department of Periodontology,
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center,
Bauxite Road,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9611725715 |
| Fax |
|
| Email |
dr.abhilashajha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Sanikop |
| Designation |
Professor |
| Affiliation |
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center |
| Address |
Department of Periodontology,
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center,
Bauxite Road,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9480498454 |
| Fax |
|
| Email |
sanikopsheetal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Jha |
| Designation |
Post-graduate |
| Affiliation |
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center |
| Address |
Department of Periodontology,
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center,
Bauxite Road,
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9611725715 |
| Fax |
|
| Email |
dr.abhilashajha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Abhilasha Jha,
Department of Periodontology,
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center,
Bauxite Road,
Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha Jha |
| Address |
Department of Periodontology,
Maratha Mandal s N. G. H Institute of Dental Sciences and Research Center,
Bauxite Road,
Belagavi |
| 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 Abhilasha Jha |
Maratha Mandal s N.G.H Institute of Dental Sciences and Research Center |
Department of Periodontology
Belgaum
KARNATAKA |
9611725715
dr.abhilashajha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJIV GANDHI UNIVERSITY OF HEALTH 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 |
| Intervention |
Carica papaya extracts |
Total duration of therapy- 45 days
Frequency of therapy- twice |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Moderate chronic periodontitis, Probing Pocket Depth of 5-7mm, Clinical attachment loss of >3mm |
|
| ExclusionCriteria |
| Details |
Systemically compromised, tobacco consumers, pregnant and lactating mothers, antibiotic usage in the past six months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical symptoms of chronic periodontitis by checking probing pocket depth, clinical attachment loss, gingival index and bleeding index |
Over a period of 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction if any |
Over a period of 45 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
23/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Herbal extracts derived from medicinal plants are
gaining wide popularity for the treatment of various diseases. This is
primarily due to the least amount of toxicity that they exhibit along with
being economical.
One such medicinal plant is Carica papaya or the pawpaw plant popularly cultivated in the
tropical belt of South-East Asia. Its properties have been
established and largely studied in medicine. However, it still is greatly
unexplored in the field of dentistry.
The aim of this study was to assess and compare the effect of Papaya (Carica papaya) raw fruit and leaf
extract on the clinical signs and symptoms of Chronic Periodontitis.
The results analysed through the pilot
study revealed that C. papaya plant extracts have a definite anti-microbial
activity against the periodontal pathogens namely P. intermedia, P. gingivalis and A. actinomycetemcomitans under laboratory conditions. Based on these evaluations, this study
was conducted to compare and assess its effect on the clinical signs and
symptoms of Chronic Periodontitis. The results derived from this study conclude that the aqueous
extracts of the epicarp of raw fruit and leaf of papaya plant used as an
adjunct to Scaling and Root Planing(SRP) have superior effect in the treatment of Chronic Periodontitis
as compared to SRP alone. It also concluded that there is no statistical
difference between the results observed of leaf and raw fruit on Day 45.
However, the intra-group differences between the two Sites A and B on Day 7 and
45 suggest that the leaf extract has a superior effect as compared to the
epicarp of raw fruit extract. This may
be attributed to the increased presence of papain and chymopapain enzymes in
the leaf as compared to the epicarp of raw fruit of the plant.
Further research should be conducted to understand
the factors behind these properties observed in C. papaya plant. It should also
be studied in a larger population for a longer duration of time. This study
concludes that the herbal extracts of papaya plant can be used as an adjunct to
SRP for the treatment of Chronic Periodontitis. It helps in paving an alternate
path through the local drug delivery systems. |