Comparative Clinical Evaluation of the Efficacy of Local Application of Ayapon Tablets Vs Sepgard Gel to Arrest Bleeding in Intraoral Open Wounds.

Completed

• Conditions: Patients undergoing any form of intraoral periodontal surgical therapy will be selected with similar bleeding parameters

• Registration Number: CTRI/2018/02/011672
• Lead Sponsor: Abhishek Singh

Brief Summary

**The aim of this study is to clinically compare a natural product likeAyapon tablet & a Synthetic product like Sepgard gel as an adjunct toarrest bleeding to resolve inflammation thereby promote faster healing.****A total of 40 patients willbe selected for this study from outpatient department of Periodontics, NairHospital Dental College, Mumbai. Audio video consent will be taken prior to thestudy and if the patient is willing to discontinue the treatment procedure during the study, he or she will be allowed to do so. In Group A Bleeding is arrested with local application of AyaponTMtablet while in Group B Bleeding is arrested with application of SepgardTM gel. Computer generated randomization method will be used as sampling method. The duration of the study is 6 months. The primary efficacy parameters are bleeding and clotting time assessment.****During the surgery local application of Ayapon tablet and Sepgard gel has to be done to arrest bleeding.The patients will be recalled at 7th day,30th day,45th day post surgery to assess any untoward effect of these products on the recipient site. The data will be analysed individually for all the patients. The values will be subjected comparison betweeen groups using unpaired student t-test. There is no conflict of interest.**

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-03
• Study Completion: 2017-10-10
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Age group between 20-45years.
• 2.Patients in good systemic health.
• 3.Patients undergoing any form of intraoral periodontal surgical therapy will be selected with similar bleeding parameters.

Exclusion Criteria

• 1.Patients suffering from any systemic diseases or with compromised immune system.
• 2.Patients with a known history of drug allergy 3.Patients taking any drug known to cause gingival enlargement 4.Patients taking any immuno-suppressive drugs like corticosteroids.
• 5.Pregnant and/or lactating mothers.
• 6.Patients with any bleeding disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Bleeding test assessment.	During the Surgery bleeding time and clotting time will be assessed with the help of an automated timer
2)Clotting time assessment.	During the Surgery bleeding time and clotting time will be assessed with the help of an automated timer

Secondary Outcome Measures

Name	Time	Method
During the surgery local application of Ayapon tablet and Sepgard gel has to be done to arrest bleeding.	The patients will be recalled at 7th day,30th day,45th day post surgery to assess any untoward effect of these products on the recipient site.

Trial Locations

Locations (1)

Nair hospital dental college; 🇮🇳 Mumbai, MAHARASHTRA, India

Nair hospital dental college

🇮🇳Mumbai, MAHARASHTRA, India

Abhishek singh

Principal investigator

9870611172

abhisingh3005@gmail.com