comparative evaluation of the effects of Bovine derived xenograft (osseograft TM) and combination of bovine derived xenograft and calcium sulphate hemihydrate (osseograftTM) , used for the treatment of bone defects due to diseases of gums, clinically and using radiograph

Completed

• Conditions: Other general symptoms and signs,

• Registration Number: CTRI/2018/01/011245
• Lead Sponsor: Nikita Dilip Patil

Brief Summary

The aim of the study is to evaluate and compare clinically and radiographically the effect of Bovine Derived Xenograft  (OsseograftTM) Alone Vs A Combination of Bovine Derived Xenograft and Calcium sulphate hemihydrate (OsseomoldTM) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients. A total of 40 patients will be selected from the outpatient department of Periodontics, Nair Hospital Dental College, Mumbai and will be equally divided into two groups of 20 each. In Group  A Bovine Derived Xenograft  (OsseograftTM) and in Group B A Combination of Bovine Derived Xenograft and Calcium sulphate hemihydrate (OsseomoldTM) will be placed as a graft in interproximal bone defects. The study is clinical interventional prospective study. Computer generated randomization method will be used as sampling method. The durtion of the study is 20 months which includes a duration of 14 months for treatment procedures and 6 months follow up. The primary efficacy parameters are plaque index, gingival index, pocket probing depth and clinical attachment level. plaque and gingival index will be recored at baseline, 1 month, 3 months and 6 months post operatively. Radiographic analysis of the surgical site will be done to measure bone fill at baseline, immediately post surgery and 6 months post surgery. The data will be analysed  individually for all the patients. The values will be subjected to comparison within and between groups using student t test and ANOVA analysis. There is no conflict of interest

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study Completion: 2019-01-02
• Last Update Posted: 2019-12-15

Recruitment & Eligibility

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

Inclusion Criteria

• 1)Age group between 20-60 2)Diagnosis with chronic periodontitis 3)Patients in good systemic health with no contraindication to periodontal surgery 4)Patients having Intrabony defects with pocket depths of >5mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
• 5)Involved teeth to be vital and asymptomatic.

Exclusion Criteria

• 1)One — wall osseous defects.
• 2)Patients suffering from any systemic diseases or with compromised immune system.
• 3)Patients who had received any type of periodontal therapy for the past 6 months 4) Patients taking any immuno-suppressive drugs like corticosteroids 5)Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
• 6)Patients showing unacceptable oral hygiene compliance during / after the phase I therapy.
• 7)Patients taking any drug known to cause gingival enlargement.
• 8)Pregnant and/or lactating mothers.
• 9)Patients who were smokers or had tobacco in any other form.
• 10)Endodontically treated teeth.
• 11)Patient on anticoagulant therapy 12)Patient with bleeding disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 Plaque Index (Turskey Gilmore-Glickman Modification of Quigley Hein)	the outcomes will be assessed pre-operatively, immediate post operatively, 3 months post operatively and 6 month post operatively
1 Probing Pocket Depth	the outcomes will be assessed pre-operatively, immediate post operatively, 3 months post operatively and 6 month post operatively
2 Clinical Attachment Level	the outcomes will be assessed pre-operatively, immediate post operatively, 3 months post operatively and 6 month post operatively
4 Gingival Index (Loe & Silness, 1963)	the outcomes will be assessed pre-operatively, immediate post operatively, 3 months post operatively and 6 month post operatively

Secondary Outcome Measures

Name	Time	Method
Radiographic bone fill will be evaluated using intra oral periapical radiographs of the surgical site	radiographs will be taken at baseline post surgery and 6 months post surgery

Trial Locations

Locations (1)

Nair Hospital Dental College; 🇮🇳 Mumbai, MAHARASHTRA, India

Nair Hospital Dental College

🇮🇳Mumbai, MAHARASHTRA, India

Nikita Dilp Patil

Principal investigator

9699696160

patilnikii19@gmail.com