Immediate Implant Placement With Connective Tissue Graft or Socket Shield

Study Overview
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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.

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

Conditions
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Tooth Fractures

Intervention / Treatment
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* Procedure: Connective tissue graft
* Procedure: socket shield technique
* Procedure: Immediate implant placement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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<br>* 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.<br>Procedure: Immediate implant placement<br>* The implant will be placed in the frest socket immediately after tooth extraction<br>|
| Experimental: Test Group<br>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: socket shield technique<br>* The procedure is used to split the teeth and preserve the buccal part<br>Procedure: Immediate implant placement<br>* The implant will be placed in the frest socket immediately after tooth extraction<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immediate implant placement, connective tissue graft, samll dehiscence