Immediate Implant Placement With Connective Tissue Graft or Socket Shield

Phase 3

• Conditions: Tooth Fractures
• Interventions: Procedure: Connective tissue graft; Procedure: socket shield technique; Procedure: Immediate implant placement

• Registration Number: NCT03594019
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-20
• Study Start: 2019-02-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Primary Completion: 2021-12-20
• Study Completion: 2022-02-01

Recruitment & Eligibility

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

Inclusion Criteria

• Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （<2mm vertical bone loss and <5mm horizontal bone loss） Patients with natural teeth adjacent to implant site

Exclusion Criteria

• Uncontrolled periodontal diseases Heavy smokers (>10 cigarettes/day) Unwilling to participate in the present study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Connective tissue graft	Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished.
Test Group	socket shield technique	Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished.
Control Group	Immediate implant placement	Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished.
Test Group	Immediate implant placement	Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished.

Primary Outcome Measures

Name	Time	Method
pink esthetic score （PES）	1 year	An objective index introduced by Furhauser et al. 2005

Secondary Outcome Measures

Name	Time	Method
marginal bone loss	1 year	the mesial and dital marginal bone loss from baseline to follow-up evaluated by peri-apical X-ray.
pocket probing depth	1 year	the pocket depth at six sites around implant will be detected by periodontal probe
bleeding on probing	1 year	the percentage of bleeding after probing by periodontal probe
mucosal recession	1 year	the mid-buccal mucosal level change from baseline to follow-up

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China