Immediate Implant Placement With Connective Tissue Graft or Socket Shield

NCT ID: NCT03594019

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-02-01

Brief Summary

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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

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Conditions

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Tooth Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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.

Group Type PLACEBO_COMPARATOR

Connective tissue graft

Intervention Type PROCEDURE

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.

Immediate implant placement

Intervention Type PROCEDURE

The implant will be placed in the frest socket immediately after tooth extraction

Test Group

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.

Group Type EXPERIMENTAL

socket shield technique

Intervention Type PROCEDURE

The procedure is used to split the teeth and preserve the buccal part

Immediate implant placement

Intervention Type PROCEDURE

The implant will be placed in the frest socket immediately after tooth extraction

Interventions

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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.

Intervention Type PROCEDURE

socket shield technique

The procedure is used to split the teeth and preserve the buccal part

Intervention Type PROCEDURE

Immediate implant placement

The implant will be placed in the frest socket immediately after tooth extraction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Junyu Shi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Ninth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junyu Shi, PhD

Role: CONTACT

081 53315299

Facility Contacts

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Junyu Shi, MDS

Role: primary

081-53315299

Other Identifiers

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2017_0419

Identifier Type: -

Identifier Source: org_study_id

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