Applying marigold plant material on the open wound after removal of a small part of the gums in the mouth and comparing its healing with that of patients own blood material. -As a medical trial.

Phase 4

Suspended

• Conditions: Other specified bacterial diseases,

• Registration Number: CTRI/2020/04/024717
• Lead Sponsor: DR BHARATH KUMAR A M

Brief Summary

**Detailed description of procedure/processe**

The study design is in-vivo randomized control clinical trial ­­­­­-Randomization will be done  by using computer method. The surgical procedures shall be follows:



The subjects fulfilling the inclusion criteria will be randomized into two groups (Group A & Group B) by computer method.



The subjects will be given the Patient information sheet (PIS) on the first day of visit.



Maxillary impression will be taken using alginate and the cast will be prepared for all the subjects participating in the       study, then the acrylic stent will be made.

 

2ml Local anesthesia 2% lidocaine (adrenaline 1:10000) will be administered at Nasopalatine and Greater palatine on the day of surgery.



Incision will be placed using blade #15 for procurement of the palatal graft. A standard measurement of width and height (1cm x 1cm) graft will be taken from all the patients.



10 ml of blood from antecubital vein of the patient will be collected in the sterile test tube without anticoagulant and       will  be centrifuged for – 12 min at the centrifugation speed at – 2700 RPM to obtain PRF for the Control Group B.

The patients who are allocated to Test group A- 1% Calendula Officinalis gel will be placed on the palatal wound and Gelatin film will be placed over and suture/glued whereas, Group B will receive Platelet Rich Fibrin (PRF) and Gelatin film will be placed over and sutured/glued.



(The 10% calendula gel will be diluted to 1% calendula by distilled water by the help of Manipal college of pharmacy.) 10% calendula officinalis is readliy available in the market (Fourrts)



Then the stent will be placed in both the groups.



The procured graft then will be used in periodontal surgery according to the patients requirement.ie; to increase the width of attached gingiva, miller class 1 or class 2 recession or Vestibuloplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-29
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients willing to participate in the study Patients undergoing plastic surgery and requiring soft tissue graft.
• Good oral hygiene No history of periodontal surgery at the operation site.

Exclusion Criteria

• History of known systemic diseases like hypertension, diabetes, HIV, radiation therapy, immunosuppressive therapy, cancer.
• Pregnancy/lactation Patients with the habit of smoking and tobacco chewing Medications known to affect the outcomes of the treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome:To observe wound closure according to the Healing Index and haemostasis.	7th day, 15th day and 2 months
Secondary outcome:To record Pain perception using verbal rating scale (VRS)	7th day, 15th day and 2 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcome:To record Pain perception using verbal rating scale (VRS)	7th day, 15th day and 2 months

Trial Locations

Locations (1)

Manipal College of dental Sciences; 🇮🇳 Udupi, KARNATAKA, India

Manipal College of dental Sciences

🇮🇳Udupi, KARNATAKA, India

DR BHARATH KUMAR A M

Principal investigator

8746842802

dr.bharathkumar1995@gmail.com