A clinical trial to assess the effect of change in bone levels following implant placement immediately after removal of tooth with and without socket shield (leaving a tooth root section)

Phase 3

Not yet recruiting

• Conditions: Healthy

• Registration Number: CTRI/2018/06/014610
• Lead Sponsor: Divya Das

Brief Summary

This randomized double blinded, parallel group active controlled clinical trial aims to compare clinically andradiographically (CBCT) the dimensional alterations in soft and hard tissues followingimmediate implant placement with and without socket shield at baseline, 3 and 6 months.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-06-20
• Study Start: 2018-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Systemically healthy adults who present with hopeless teeth indicated for extraction and are willing for immediate implant placement.
• Tooth indicated for extraction should be periodontally healthy.
• Non smoker.

Exclusion Criteria

Systemically unhealthy Teeth with present / past periodontal disease Teeth with vertical root fractures on the buccal aspect Teeth with horizontal fractures at / below bone level Teeth with external / internal resorption of buccal part of root Patients who are pregnant, intending to conceive or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the dimensional alterations in bone level (buccal plate) radiographically (CBCT) and clinically by transgingival probing at baseline, 3 months and at 6 months.	Baseline, 3 months and at 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the soft tissue around the implant using the Pink Esthetic Score (PES), implant mobility and signs of peri – implantitis. Assessment of pain threshold and patient satisfaction using Visual Analogue Scale (VAS).	The soft tissue around the implant will be assessed using the Pink Esthetic Score (PES). Assessment of implant mobility and signs of peri – implantitis will be evaluated. Assessment of pain threshold and patient satisfaction using Visual Analogue Scale (VAS)at baseline, 3 months and at 6 months.

Trial Locations

Locations (1)

Sri Ramachandra Medical College and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Medical College and Research Institute

🇮🇳Chennai, TAMIL NADU, India

Divya Das

Principal investigator

9790754096

dasdivya1893@gmail.com