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

Semmelweis University

Status: Enrolling

Conditions: Alveolar Bone Loss

Treatments: Procedure: Socket seal technique; Procedure: Extraction site development technique; Device: autogenous tooth bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT05674331

ARP-Semmelweis-Paro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

socket seal group

Active Comparator group

Description:

After tooth extraction a soft tissue pounch is sutured above the extraction socket.

Treatment:

Procedure: Socket seal technique

XSD+ socket seal group

Experimental group

Description:

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.

Treatment:

Procedure: Extraction site development technique

Procedure: Socket seal technique

XSD+ ATB+socket seal group

Experimental group

Description:

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.

Treatment:

Device: autogenous tooth bone graft

Procedure: Extraction site development technique

Procedure: Socket seal technique