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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05674331
Other study ID # ARP-Semmelweis-Paro
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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