| CTRI Number |
CTRI/2023/08/056302 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing and evaluating the pain perception and wound healing effectiveness of 2 different medications Triphala Guggulu or Ketrolac tromethamine after periodontal flap surgery. |
|
Scientific Title of Study
|
Analgesic, anti-inflammatory and wound healing efficacy of Triphala Guggulu and Ketrolac tromethamine after periodontal flap surgery -A randomized double-blind 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 Alsha Thankam George |
| Designation |
I MDS |
| Affiliation |
KVG Dental College and Hospital |
| Address |
KVG Dental College and Hospital,
Dakshina Kannada, Sullia,
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8078337581 |
| Fax |
|
| Email |
dralshageorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivananda H |
| Designation |
Reader |
| Affiliation |
KVG Dental College and Hopsital |
| Address |
KVG Dental College & Hospital, Dakshina Kannada , Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
08078337581 |
| Fax |
|
| Email |
Shivanand_perio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Alsha George |
| Designation |
I MDS |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
KVG Dental College and Hospital, Dakshina Kannada, Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
08078337581 |
| Fax |
|
| Email |
dralshageorge@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital, Dakshina Kannada,Sullia |
|
|
Primary Sponsor
|
| Name |
Dr Alsha Thankam George |
| Address |
KVG Dental College and Hospital, Dakshina Kannada , Sullia |
| Type of Sponsor |
Private medical college |
|
|
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 Alsha |
KVG Dental College and Hospital |
Department of Periodontology Room no 11,Kurunjibhag,Sullia,574327
Dakshina Kannada
KARNATAKA |
8078337581
dralshageorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: UPAKUSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRIPHALA GUGGULU, Reference: SARANGADHARA MADHYAMA KHANDA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | KETROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE is a nonsteroidal anti-inflammatory analgesics drugs NSAIDs)used
in dental treatment. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Maintenance of good oral hygiene after phase 1 therapy.
2.age ranging from 30 years to 65 years.
3.patients who are systemically healthy.
4.patients who are willing to participate in this study.
5.probings pocket depth >5mm or clinical attachment >3mm in atleast 3 teeth in more than one sextant after phase one therapy. |
|
| ExclusionCriteria |
| Details |
1.The patients who are undergoing treatment with analgesics or corticosteroids during the trial period.
2.patients with history or clinical evidence of allergy to ketorolac tromethamine and Triphala guggulu.
3.pregnancy and lactating mothers.
4. smokers and alcoholics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to measure the mean post-operative pain using visual analog scale |
After periodontal flap surgery, visual analog scale will be measured immediately after surgery, hourly intervals from 1 to 8 hours on the day of
surgery and 2 times (morning and night) on the 2
and 3rd postoperative days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the postoperative tissue response & wound healing after periodontal flap surgery |
Tissue response, which is tissue edema, tissue color (TC), & wound healing will be assessed after 1 week postoperatively |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/08/2023 |
| 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 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 - NO
|
|
Brief Summary
|
All the patients will be selected from the outpatient section of the Department of Periodontology, KVG Dental College and Hospital, Sullia. 20 subjects diagnosed with periodontitis undergoing periodontal flap surgeries will be selected for the study. Sextants are selected randomly and divided into 2 groups, Group A and Group B. Group A will be given 2 tabs Triphala Guggulu 500mg, 30 mins before the administration of local anesthesia and group B will be given 1 tab ketorolac tromethamine 10mg,30 mins before the administration of local anesthesia. The subjects in Group A will be given 2 tabs of Triphala Guggulu 500mg and Group B 1 tab of ketorolac tromethamine 10mg after 8 hours from the completion of the surgical procedure. After the surgery, a customized chart will be provided to the subject, to self-report postoperative pain using a visual analog scale (VAS). VAS will be measured immediately after surgery, hourly intervals from 1 to 8 hours on the day of surgery and 2 times (morning and night) on the 2 and 3rd postoperative days. The following parameters will be assessed- 1. Tissue response - Based on Sanz-Moliner JD et al,2013 visual analysis 2. The early wound healing scale Based on Landry et al Statistical analysis will be performed to compare the changes in clinical parameters between Group A and Group B Prior to the surgical procedure, all participants will have an examination and treatment planning appointment and will receive oral hygiene instructions as well as initial scaling and root planing treatment. Flap surgery will be conducted under the standard protocol. The patients will be recalled after one week postoperatively for suture removal and assessment of clinical parameters.
SURGICAL PROCEDURE Subjects that meet the inclusion criteria will be chosen for flap surgery. Preoperatively patients will be given chlorhexidine mouthwash 0.12%(perioguard)for mouth rinsing before giving local anesthesia. All aseptic precautions and standard protocol will be followed during flap surgery. Group A will be given 2 tabs Triphala guggulu 500mg (PATANJALI) 30 mins before the administration of local anesthesia and group B will be given 1tab ketorolac tromethamine 10mg (KetorolTM-DT) 30 mins before the administration of local anesthesia All the patients will be treated using 2%lignocaine hydrochloride with adrenaline in 1:80000 concentrations (Lignox2%-A). Incisions will be placed with B.P blade no 15 on the buccal and lingual surface and B.P no 12 on the interdental region. Following reflection and debridement, the surgical site will be irrigated and flap approximation will be using 4-0 silk suture and covered with a periodontal dressing(coe-pack). Post-operative instruction will be given. The subjects in Group A will be given 2 tabs of Triphala Guggulu 500mg and Group B 1 tab of ketorolac tromethamine 10mg after 8 hours from the completion of the surgical procedure. The patients will be recalled after one week postoperatively for suture removal and assessment of clinical parameters.
POST-OPERATIVE RECALL Subjects will be reviewed after the 7th day for evaluation of clinical parameters. A customized chart will be provided to the subject, to self-report postoperative pain using a visual analog scale (VAS) . VAS will be measured immediately after surgery, hourly intervals from 1 to 8 hours on the day of surgery and 2 times (morning and night) on the 2nd and 3rd postoperative days. |