Reconstruction of Localized Alveolar Ridge Defects

Phase 4

Recruiting

• Conditions: Partial-edentulism
• Interventions: Procedure: Full-thickness group; Procedure: Split-thickness group

• Registration Number: NCT05538715
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study Start: 2019-11-08
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full-thickness group	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.
Split-thickness group	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.

Primary Outcome Measures

Name	Time	Method
Orovestibular ridge width	6 months postoperatively	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.
Dimensional change of keratinized Gingiva	6 months postoperatively	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary