Clinical trial NCT05674331: Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
Official title: Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Hard- and Soft- Tissue Changes Following Alveolar Ridge Preservation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: alveolar ridge preservation
autogenous tooth bone graft
extraction side development technique
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Horizontal ridge width changes
timeFrame: during first surgery and during 6 months reentry
Secondary outcomes:
measure: Evaluation of change of alveolar ridge width on CBCT
timeFrame: at baseline and 6 months postoperatively
measure: Evaluation of change of alveolar ridge height on CBCT
timeFrame: at baseline and 6 months postoperatively
measure: Evaluation of change of alveolar ridge volume on CBCT
timeFrame: at baseline and 6 months postoperatively
measure: Monitoring the microvascularization
timeFrame: Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
measure: Examination of early wound healing phase
timeFrame: Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
measure: Soft tissue volumetric changes
timeFrame: analysis of baseline and 6-month post-alveolar digital impressions
measure: Histomorphometry
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
affiliation: Department of Periodontology,Semmelweis University
name: Balint Molnar
role: PRINCIPAL_INVESTIGATOR
References: