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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674331
• Other study ID #: ARP-Semmelweis-Paro
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: Semmelweis University
• Contact: Eleonora Solyom, DMD
• Phone: 0036304636885
• Email: eleonorasolyom[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal ridge width changes	The primary outcome is the alveolar ridge width change in millimeter intraoperatively, measured immediately after the tooth extraction and after 6 months at the reentry procedure (at the time of implant placement).	during first surgery and during 6 months reentry
Secondary	Evaluation of change of alveolar ridge width on CBCT	Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets	at baseline and 6 months postoperatively
Secondary	Evaluation of change of alveolar ridge height on CBCT	Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets	at baseline and 6 months postoperatively
Secondary	Evaluation of change of alveolar ridge volume on CBCT	Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets	at baseline and 6 months postoperatively
Secondary	Monitoring the microvascularization	Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging	Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Secondary	Examination of early wound healing phase	Examination of early wound healing phase by means of clinical photdocumentation	Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Secondary	Soft tissue volumetric changes	Assessment of soft tissue volumetric changes by intraoral scanning	analysis of baseline and 6-month post-alveolar digital impressions
Secondary	Histomorphometry	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	6 months postoperatively