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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03594019
Other study ID # 2017_0419
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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