Immediate Implant Placement With Connective Tissue Graft or Socket Shield

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

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.

Study Overview

• Status: Unknown
• Conditions: Tooth Fractures
• Intervention / Treatment: Procedure: Connective tissue graft; Procedure: Immediate implant placement; Procedure: socket shield technique

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200011
    • Recruiting
    • Shanghai ninth people's hospital
    • Contact: Junyu Shi, MDS; Phone Number: 081-53315299; Email: sakyamuni_jin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	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.; Procedure: Immediate implant placement; The implant will be placed in the frest socket immediately after tooth extraction
EXPERIMENTAL: 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.	Procedure: Immediate implant placement; The implant will be placed in the frest socket immediately after tooth extraction; Procedure: socket shield technique; The procedure is used to split the teeth and preserve the buccal part

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pink esthetic score （PES）	An objective index introduced by Furhauser et al. 2005	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): December 20, 2021
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: connective tissue graft; immediate implant placement; samll dehiscence
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Tooth Fractures
• Other Study ID Numbers: 2017_0419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No