Comparing two surgical techniques for bone augmentation in dental patients

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

This study is testing whether a new surgical method for bone augmentation in dental patients works better than the traditional method to see how well they heal and how their tissues change after surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Semmelweis University (other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Budapest)
• Trial ID: NCT05538715 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a novel split-thickness mucoperiosteal flap technique against a conventional full-thickness flap technique during horizontal alveolar ridge augmentation in patients with partial edentulism. The study will assess clinical outcomes, radiological changes, micro-circulation, and histological results over a six-month period. Participants will be randomly assigned to either the test group or the control group, with evaluations focusing on healing and tissue changes post-surgery. The use of advanced imaging techniques like Laser Speckle Contrast Imaging will enhance the understanding of micro-circulation during the healing process.

Who should consider this trial

Good fit: Ideal candidates include individuals with at least one edentulous maxillary or mandibular premolar or molar site experiencing horizontal bone loss.

Not a fit: Patients with active infectious diseases, significant systemic conditions, or those undergoing certain treatments like chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and faster healing for patients undergoing dental bone augmentation.

How similar studies have performed: Previous studies have shown promising results with similar surgical techniques, but this specific approach is novel and has not been extensively tested.

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

Where this trial is running

Budapest

• Semmelweis University Department of Periodontology — Budapest, Hungary (RECRUITING)

Study contacts

• Study coordinator: Bálint Molnár, DMD, PhD

Conditions: Partial-edentulism, guided surgery, xenogenic graft, augmentation, surface scanning, Laser Speckle Contrast Imaging