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

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.

Study Overview

• Status: Recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Socket seal technique; Procedure: Extraction site development technique; Device: autogenous tooth bone graft

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.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleonora Solyom, DMD; Phone Number: 0036304636885; Email: eleonorasolyom@gmail.com
• Study Contact Backup: Name: Daniel Palkovics, DMD; Phone Number: 0036308940408; Email: dpalkovics@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Recruiting
    • Semmelweis University Department of Periodontology
    • Contact: Eleonora Solyom, DMD; Phone Number: 0036304636885; Email: eleonorasolyom@gmail.com
    • Contact: Balint Molnar, DMD, PhD; Phone Number: 0036302553334; Email: molbal81@gmail.com
    • Principal Investigator: Balint Molnar, DMD, Phd
    • Principal Investigator: Eleonora Solyom, DMD
    • Sub-Investigator: Reka Fazekas, DMD, PhD
    • Sub-Investigator: Daniel Palkovics, DMD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: socket seal group; After tooth extraction a soft tissue pounch is sutured above the extraction socket.	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.
Experimental: XSD+ socket seal group; After tooth extraction for the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.	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.; 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 .; Other Names: XSD
Experimental: XSD+ ATB+socket seal group; After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.	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.; 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 .; Other Names: XSD; 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.; Other Names: ATB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.
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.
Soft tissue volumetric changes	Assessment of soft tissue volumetric changes by intraoral scanning	analysis of baseline and 6-month post-alveolar digital impressions
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

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Balint Molnar, Department of Periodontology,Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: alveolar ridge preservation; autogenous tooth bone graft; extraction side development technique
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: ARP-Semmelweis-Paro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No