Horizontal Ridge Augmentation Using Polyvinylidene Fluoride Versus Titanium Mesh Membranes - A Randomized Clinical Trial

Alveolar ridge resorption following tooth loss frequently results in horizontal deficiencies that complicate optimal implant placement. To address this, guided bone regeneration (GBR) techniques have become standard in clinical practice, relying on barrier membranes to stabilize graft material and exclude soft tissue interference during healing Titanium mesh membranes have been widely utilized in GBR due to their excellent mechanical strength and ability to maintain space in large or complex defects. Their rigidity ensures stability of the graft material, promoting favorable bone regeneration outcomes. However, the stiffness of titanium meshes can lead to complications such as soft tissue dehiscence and membrane exposure, potentially compromising the regenerative process On the other hand, polyvinylidene fluoride (PVDF) membranes have emerged as a promising alternative in GBR procedures. PVDF is a biocompatible, chemically stable polymer known for its flexibility and resistance to bacterial colonization. Its pliable nature allows for better adaptation to the defect site, potentially reducing the risk of membrane exposure and associated complications. Additionally, the smooth surface of PVDF membranes may minimize soft tissue irritation, further enhancing healing outcomes Materials and methods Study design and patient selection This study was designed as a randomized, controlled, parallel-arm, triple-blinded clinical trial aimed at rigorously comparing the clinical and radiographic outcomes of ridge augmentation procedures utilizing two distinct materials: titanium mesh and high-density polyvinylidene fluoride (PVDF) membrane. In this trial, participants, clinical outcome assessors, and statisticians were kept blind to the treatments being administered to mitigate bias. However, due to the inherent nature of the surgical procedures involved, the operating surgeon could not be blinded.

Participants were selected from the outpatient clinic at the Department of Oral Medicine, Oral Diagnosis, and Periodontology at the Faculty of Dentistry, Nahda University, Beni Suef, Egypt. Inclusion criteria were clearly defined, ensuring that only eligible candidates participated in the study. Prior to enrollment, written informed consent was meticulously obtained from all participants after providing a thorough explanation of the experimental procedures, potential risks, and anticipated benefits associated with their involvement in the research.

The study was conducted in strict adherence to the ethical principles outlined in the Declaration of Helsinki. Additionally, it complied with the International Conference on Harmonization Good Clinical Practice Guidelines. The Research Ethics Committee at the Faculty of Dentistry, Minia University, Minia, Egypt, granted approval for the study, which was registered under a specific registration number ( ) to ensure compliance and transparency in the research process. (clinical trial registration number) 2.2 | Patient Selection

Patient selection underwent stringent selection criteria as follows:

Inclusion criteria: