Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is: • effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.

Detailed Description
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Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.

Official Title
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Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone

Conditions
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Peri-implant Tissue Response With Use of Customized Healing Abutments

Intervention / Treatment
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* Procedure: customized healing abutment
* Procedure: standard healing abutment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age; patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration; had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm. Exclusion Criteria: medical and general contraindications for the surgical procedure; heavy smokers (>10 cigarettes/day); an active infection at the implant site.

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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Accepts Healthy Volunteers

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
Interventional Model Description: patients in each group will received different types of customized healing abutment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized group<br>patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle | Procedure: customized healing abutment<br>* patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.<br>|
| Experimental: Standard group<br>patients who received standard titanium healing abutments following implant placement | Procedure: standard healing abutment<br>* patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| soft tissue alteration | peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points | T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up | 
| hard tissue alteration | peri-implant marginal bone change compared to baseline at different time points by periapical radiograph | T0 baseline before implant placement, 6month follow up, 12month follow up | 
| volumetric alteration | peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan | T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain numerical rating scale | pain assessment at time of final prosthesis delivery with scale from 0 to 10 | at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery | 
| pink esthetic score | pink esthetic score change compared to before implant treatment | T0 baseline before implant placement, 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, customized healing abutment