Clinical trial NCT05538715: Reconstruction of Localized Alveolar Ridge Defects
Official title: Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Partial-edentulism
Keywords: guided surgery
xenogenic graft
augmentation
surface scanning
Laser Speckle Contrast Imaging
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
name: Institut Straumann AG
name: Dicomlab Kft.
First posted: 2022-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Orovestibular ridge width
timeFrame: 6 months postoperatively
measure: Dimensional change of keratinized Gingiva
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Histomorphometrical analysis
timeFrame: Following reentry 6 months after augmentation
measure: Gingival blood flow measurement at the early wound healing phase
timeFrame: Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References: