Comparing and evaluating the pain perception and wound healing effectiveness of 2 different medications Triphala Guggulu or Ketrolac tromethamine after periodontal flap surgery.
- Conditions
- Chronic periodontitis. Ayurveda Condition: UPAKUSAH,
- Registration Number
- CTRI/2023/08/056302
- Lead Sponsor
- Dr Alsha Thankam George
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- 1.Maintenance of good oral hygiene after phase 1 therapy.
- 2.age ranging from 30 years to 65 years.
- 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.
- 1.The patients who are undergoing treatment with analgesics or corticosteroids during the trial period.
- 3.pregnancy and lactating mothers.
- smokers and alcoholics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
KVG Dental College and Hospital
🇮🇳Kannada, KARNATAKA, India
KVG Dental College and Hospital🇮🇳Kannada, KARNATAKA, IndiaDr AlshaPrincipal investigator8078337581dralshageorge@gmail.com