NCT05538715

Reconstruction of Localized Alveolar Ridge Defects

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Partial-edentulism

Interventions

Type	Name	Description
PROCEDURE	Split-thickness 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.
PROCEDURE	Full-thickness 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.

Timeline

• Start date: 2019-11-08
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-09-14
• Last updated: 2023-11-27

Locations

1 site across 1 country: Hungary