Evaluating techniques for preserving alveolar bone after tooth extraction

Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Hard- and Soft- Tissue Changes Following Alveolar Ridge Preservation

This study is testing different ways to help preserve jawbone after a tooth is pulled to see which method works best for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Semmelweis University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Budapest)
• Trial ID: NCT05674331 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of different techniques for alveolar ridge preservation (ARP) following tooth extraction. Participants will be divided into three groups: one receiving a socket seal, another combining socket seal with an extraction side development technique (XSD), and the last using XSD with an autogenous tooth bone graft (ATB). The primary outcome will measure changes in alveolar ridge width immediately after extraction and six months later, alongside secondary outcomes such as gingival microvascularization and soft tissue volumetric changes. The study will involve 63 participants in total, with careful monitoring of various parameters to determine the best approach for ARP.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with periodontal disease requiring tooth extraction and who maintain good oral hygiene.

Not a fit: Patients with infectious diseases, significant systemic conditions affecting bone metabolism, or those undergoing current chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved techniques for preserving alveolar bone, enhancing outcomes for patients requiring dental implants.

How similar studies have performed: Previous studies have shown promising results with similar techniques for alveolar ridge preservation, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Women and men Patients over 18 years Co-operative patients with good individual oral hygiene (FMBS: 25%\>) Patients with periodontal disease in treatment or under treatment with minimal active inflammation (FMPS: 25%\>)

Local criteria:

Teeth with a hopeless prognosis with advanced periodontal or endo-periodontal defects, which are restored with implant prosthesis EDS 3-4 extraction defects after tooth extraction

Exclusion Criteria:

* Infectious diseases (HBV, HCV, HIV, CoV-2019...) Current chemotherapy or radiotherapy Previous radiation therapy to the head and neck region (in the last 2 years) Untreated insulin dependent diabetes mellitus Clinically significant osteoporosis or other systemic disease affecting bone metabolism Clinically significant circulatory disorder e.g.: decompensated cardiac failure Haemodynamically significant valvular heart failure or myocardial infarction within the last 3 months Clinically significant coagulopathy Current or previous systemic corticosteroid therapy (in the last 2 months) Current or previous systemic bisphosphonate therapy (beyond 30 days) Pregnant or breastfeeding women Smoking (max 5 cigarettes per day) Drug addiction, alcoholism

Where this trial is running

Budapest

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

Study contacts

• Principal investigator: Balint Molnar — Department of Periodontology,Semmelweis University
• Study coordinator: Eleonora Solyom, DMD

Conditions: Alveolar Bone Loss, alveolar ridge preservation, autogenous tooth bone graft, extraction side development technique