NCT05674331

Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

With alveolar ridge preservation (ARP) ridge resorption following extraction may be reduced. Several materials and techniques have been advocated for ARP. The aim of our randomised clinical trial is to evaluate the efficacy of extraction side development technique (XSD) and autogenous tooth bone graft (ATB) for ARP.

Detailed description

A three armed clinical study will be established. According to the sample size calculation, every arm will contain 21 participants. The first group is the socket seal group. In the second group we aim to combine the socket seal and XSD technique. In the third group the XSD technique will be combined with the ATB material. The primary outcome is the alveolar ridge width change in millimeter, measured immediately after the tooth extraction and after 6 months at the reentry procedure. The change in alveolar ridge width and vertical dimensional alterations will be also measured as secondary outcomes on the CBCT at baseline and after 6 months. Further secondary outcomes are the monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging and assessment of soft tissue volumetric changes by intraoral scanning and histomorphometric evaluation of the volumetric percentage of newly formed bone, connective tissue and graft material after a 6-month healing period in a core biopsy taken at the time of implant placement. Hypothesis: The XSD and XSD+ATB groups are expected to have less pronounced horizontal width losses. XSD group is expected to produce the highest graft turnover.

Conditions

• Alveolar Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Extraction site development technique	The technique is described by Molnar et al. in 2019. The aim is to reconstruct the buccal bony wall with a xenogenic membrane with a slow absorption rate properties. This technique aims to stabilizate and enlarge the blood clot .
DEVICE	autogenous tooth bone graft	ATB was invented by Kim et al. in 2011. The extracted tooth is grinded and goes throw a sterilization procedure by the manufacturer's recommendation. The graft material can be used immediately for ARP.
PROCEDURE	Socket seal technique	After tooth removal neither graft nor any membrane material is inserted to the extraction socket. A soft tissue pounch is harvested from the hard palate and it is fixed above the extraction socket with single interrupted sutures.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2023-01-06
• Last updated: 2024-04-23

Locations

1 site across 1 country: Hungary