MedDataX Logo

Reconstruction of Localized Alveolar Ridge Defects

NCT ID: NCT05538715

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Partial-edentulism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants are not aware of the randomly assigned flap design. Independent examiners are not aware of patient allocation during analysis of clinical and radiographic data.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Split-thickness group

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Full-thickness group

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Geistlich Pharma AG

INDUSTRY

Sponsor Role collaborator

Institut Straumann AG

INDUSTRY

Sponsor Role collaborator

Dicomlab Kft.

UNKNOWN

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Semmelweis University Department of Periodontology

Budapest, , Hungary

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hungary

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bálint Molnár, DMD, PhD

Role: CONTACT

[email protected]
0036302553334

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Balint Molnar, DMD, PhD

Role: primary

[email protected]
0036302553334

Peter Windisch, DMD, PhD

Role: backup

[email protected]
0036208250310

References

Explore related publications, articles, or registry entries linked to this study.

Somodi K, Dobos A, Bartha F, Solyom E, Windisch P, Palkovics D, Molnar B. Changes in soft tissue dimensions following horizontal guided bone regeneration with a split-thickness flap design - evaluation of 8 cases with a digital method. Head Face Med. 2024 Sep 28;20(1):53. doi: 10.1186/s13005-024-00456-8.

Reference Type DERIVED
PMID: 39342334 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Augmentation-Semmelweis-Perio

Identifier Type: -

Identifier Source: org_study_id