Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation

Study Overview
=================
Brief Summary
-----------------
It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

Detailed Description
-----------------
Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.

Official Title
-----------------
Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Procedure: Transmucosal Technique
* Procedure: Submerged Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 21 years - ASA I or II. Patient's willingness to participate in this study. Availability for 4-month follow-up. Absence of active periodontal disease. Single tooth replacement is needed with simultaneous contour augmentation. Available pre-operative CBCT study. Extraction of tooth at least 8 weeks prior to planned implant therapy. Exclusion Criteria: Pregnancy at the screening visit. Smoking more than 10 cig/day. Active infection at the site of surgery (teeth involved). Multiple missing teeth adjacent to each other (long span edentulous area). Vertical bone defect less than 2mm (intra surgical assessment)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transmucosal (Non-Submerged)<br>Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure | Procedure: Transmucosal Technique<br>* Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).<br>* Other names: Non-submerged technique;|
| Active Comparator: Submerged<br>Flaps will be advanced to achieve primary wound closure. | Procedure: Submerged Technique<br>* Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hard tissue healing around dental implants | bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue healing around dental implants | Soft tissue healing around Submerged and Non-submerged dental implants. Fisher's exact test will be used to evaluate soft tissue healing changes through analyzing the measurements obtained by periodontal probe and radiographs. | 4 months |