Reconstruction of Localized Alveolar Ridge Defects

Study Overview
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Brief Summary
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The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.

Detailed Description
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The aim of our study was to compare the clinical, radiological, circulatory, and histological studies of a novel, split-thickness and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation surgeries. Flap formation was performed in the test group using the novel split-thickness surgical technique, and in the control group using the full-thickness mucoperostatial surgical technique. The novel split-thickness flap technique to be studied results in a predictable, closed healing based on our preliminary results, thus ensuring the conditions for successful augmentation. We primarily want to investigate what hard and soft tissue changes result from ridge augmentation with a novel split-thickness flap technique after 6 months, compared to a surgical technique based on full thick flap formation accepted as a standard procedure in the literature. Our secondary examination methods: examination of early wound healing and micro-circulation after augmentation interventions by LSCI method; histological evaluation at prosthetically designed implant positions.

Official Title
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Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/

Conditions
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Partial-edentulism

Intervention / Treatment
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* Procedure: Split-thickness group
* Procedure: Full-thickness group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one edentulous maxillary/mandibulary premolar or molar site with horizontal bone loss full- mouth plaque and bleeding scores (FMPS and FMBS) <20% good patient compliance (including willingness to participate in the follow-up procedures) signed informed consent- Exclusion Criteria: Active infectious diseases (HBV, HCV, HIV, TB, SARS CoV-2, etc.) Current chemotherapy or radiotherapy Radiation treatment of the former head and neck region (not older than 2 years) Untreated insulin-dependent diabetes mellitus Clinically significant osteoporosis or other systemic disease affecting bone metabolism Clinically significant circulatory disorders such as decompensated cardiac failure Haemodynamically significant heart failure or myocardial infarction within the last 3 months Clinically significant coagulation disorder Current or previous systemic corticosteroid therapy (not older than 2 months) Current or previous systemic bisphosphonate therapy Pregnant or breastfeeding mothers Smoking Drug addiction, alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Test group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. Control group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split-thickness group<br>Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. | Procedure: Split-thickness group<br>* Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.<br>|
| Experimental: Full-thickness group<br>Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. | Procedure: Full-thickness group<br>* Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orovestibular ridge width | On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of the surgical area. | 6 months postoperatively | 
| Dimensional change of keratinized Gingiva | Pre-and postoperatively a surface scan is performed using a Planmeca Emerald intraroral scanner. The superimposition of the measurements was used to evaluate the soft tissue changes associated with the treatments in 3 dimension. | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometrical analysis | Percentage of newly formed bone, bone substitute and connective tissue | Following reentry 6 months after augmentation | 
| Gingival blood flow measurement at the early wound healing phase | Investigation of pre- and postoperative gingival blood flow using Laser Speckle Contrast Imager. | Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guided surgery, xenogenic graft, augmentation, surface scanning, Laser Speckle Contrast Imaging