Immediate Implant Placement With Connective Tissue Graft or Socket Shield

Tooth Fractures Clinical Trial

Official title:

Immediate Implant Placement Without Connective Tissue Graft or Socket Shield: a Randomized Controlled Clincial Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594019
• Other study ID #: 2017_0419
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Junyu Shi, PhD
• Phone: 081 53315299
• Email: sakyamuni_jin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Fractures

Intervention

Procedure:
• Connective tissue graft
Connective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites.
• socket shield technique
The procedure is used to split the teeth and preserve the buccal part
• Immediate implant placement
The implant will be placed in the frest socket immediately after tooth extraction

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pink esthetic score (PES)	An objective index introduced by Furhauser et al. 2005	1 year
Secondary	mucosal recession	the mid-buccal mucosal level change from baseline to follow-up	1 year
Secondary	marginal bone loss	the mesial and dital marginal bone loss from baseline to follow-up evaluated by peri-apical X-ray.	1 year
Secondary	pocket probing depth	the pocket depth at six sites around implant will be detected by periodontal probe	1 year
Secondary	bleeding on probing	the percentage of bleeding after probing by periodontal probe	1 year