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

Not Applicable

Recruiting

• Conditions: Alveolar Bone Loss

• Registration Number: NCT05674331
• Lead Sponsor: Semmelweis University

Brief 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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Horizontal ridge width changes	during first surgery and during 6 months reentry	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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of change of alveolar ridge height on CBCT	at baseline and 6 months postoperatively	Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets
Evaluation of change of alveolar ridge volume on CBCT	at baseline and 6 months postoperatively	Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets
Evaluation of change of alveolar ridge width on CBCT	at baseline and 6 months postoperatively	Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets
Monitoring the microvascularization	Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.	Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging
Examination of early wound healing phase	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 by means of clinical photdocumentation
Soft tissue volumetric changes	analysis of baseline and 6-month post-alveolar digital impressions	Assessment of soft tissue volumetric changes by intraoral scanning
Histomorphometry	6 months postoperatively	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

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary