Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft

Study Overview
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Brief Summary
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Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

Detailed Description
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Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).

Official Title
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Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft. A 1-Year Randomized Clinical Trial

Conditions
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Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement

Intervention / Treatment
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* Procedure: Connective tissue graft /Bone graft/ Customized HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient-related criteria: Adults at or above the age of 18. Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy. The failing tooth will have adjacent and opposing natural teeth. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration. Able to tolerate surgical periodontal procedures. Good oral hygiene. Compliance with the maintenance program. Provide informed consent. Accepts the one-year follow-up period. Teeth related criteria: Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue. Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT. Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm Exclusion Criteria: Patients diagnosed with periodontal diseases. Current or previous smokers. Pregnant and lactating females. Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis. Patients with active infection related at the site of implant/bone graft placement. Patients with parafunctional habits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: immediate implant placement with bone grafts till crest<br>Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment. | Procedure: Connective tissue graft /Bone graft/ Customized HA<br>* Soft tissue management and augmentation<br>* Other names: Customized Healing abutment;|
| Experimental: immediate implant placement with customized healing abutment<br>Group 2 (intervention 1 group): immediate implant placement with customized healing abutment | Procedure: Connective tissue graft /Bone graft/ Customized HA<br>* Soft tissue management and augmentation<br>* Other names: Customized Healing abutment;|
| Experimental: immediate implant placement with CTG and customized healing abutment.<br>Group 3 (intervention 2 group): immediate implant placement with CTG and customized healing abutment. | Procedure: Connective tissue graft /Bone graft/ Customized HA<br>* Soft tissue management and augmentation<br>* Other names: Customized Healing abutment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid facial recession | will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bucco-palatal bone width | Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland. | 12 months | 
| Volumetric analysis of buccal contour | To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts | 12 months |