| CTRI Number |
CTRI/2024/02/062302 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to understand the healing of gum surgery with enzymes |
|
Scientific Title of Study
|
Assessment of post-surgical healing and patient reported outcomes of adjunctive systemic enzyme therapy after periodontal flap surgery- A randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N V S Sruthima G |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of periodontics and implantology, block-2, room no-7,
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293808 |
| Fax |
|
| Email |
sruthima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Garapati Nitya Sri |
| Designation |
Under Graduate Student |
| Affiliation |
Vishnu Dental college |
| Address |
Department of periodontics and implantology, block-2, room no-7,
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8688155211 |
| Fax |
|
| Email |
garapatinityasri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Garapati Nitya Sri |
| Designation |
Under Graduate Student |
| Affiliation |
Vishnu Dental college |
| Address |
Department of periodontics and implantology, block-2, room no-7,
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8688155211 |
| Fax |
|
| Email |
garapatinityasri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur,Bhimavaram
Pin-534202 west godavari
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Garapati Nitya sri |
| Address |
Department of periodontics and implantology, Vishnu Dental College,
Vishnupur, 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 Sruthima NVS G |
Vishnu Dental College |
Department of periodontics,Block 2,
Vishnu Dental College,vishnupur,bhimavaram,Andhra pradesh
West Godavari
ANDHRA PRADESH |
0881625083
Sruthima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE ,VISHNU DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NSAID group |
After the periodontal flap surgery the participants will be prescribed with Tab Diclofenac sodium, BID for five days. |
| Intervention |
Systemic Enzyme Therapy group |
After the periodontal flap surgery the participants will be prescribed with systemic enzymes in the form of Phlogam®tablets each providing 90 mg (450 FIP units) bromelain from pineapple, 48 mg (1440 FIP units) trypsin from bovine and porcine pancreas, and 100 mg rutin from Sophora Japonica, BID for five days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with persistent probing pocket depths of ≥5mm in at least four adjacent teeth (Periodontitis Stage II, III and Grade B, C) |
|
| ExclusionCriteria |
| Details |
1.Patients who have any active infections i.e., periapical, periodontal or odontogenic lesion
2.Any allergic reactions to the components of the systemic enzyme supplement
3.Severe congenital or acquired coagulation disorders (e.g. hemophilia, in dialysis patients) or liver damage,
4.Pregnancy or breastfeeding,
5.Any clinical signs or laboratory evidence for severe inflammatory, endocrine, renal/pulmonary, neurological, cardiovascular, metabolic, gastrointestinal, hematological, or psychiatric condition
6.Active malignancy of any type
7.Current use of anticoagulants or platelet aggregation inhibitors, chemotherapeutic agents, antibiotics, medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders
8.Use of NSAID within 1 month of entering the study,
9.Alcoholism, smoking,
10.Current use of nutritional supplements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early wound healing score (EHS) |
T1-7days post surgically
T2-14 days post surgically
T3-30days post surgically |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain using Visual analog scale (VAS) |
T1-7 days post surgically
T2-14 days post surgically
T3-30 days post surgically |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response (Others) - NA
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NA
- For how long will this data be available start date provided 31-12-2023 and end date provided 30-06-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Title:Assessment of Postsurgical healing and patient reported outcomes of systemic enzyme therapy after periodontal flap surgery- A randomized clinical trial
Objectives: To evaluate the effectiveness of systemic enzyme therapy post surgically in patients after periodontal flap surgery To compare and evaluate the effectiveness of systemic enzyme therapy against NSAIDs among post operative healing and pain after periodontal flap surgery
Methodology The objectives of the present study are (1) to assess healing after periodontal surgery using Early wound healing score (EHS) at 7, 14, and 30 days postoperatively, and (2) to assess pain after periodontal surgery using Visual Analog Score (VAS) at 7, 14 days postoperatively, and (3)to compare the post operative healing and pain between groups.
Source of the data:Patients attending Vishnu dental college.
|