Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedApril 23, 2024
April 1, 2024
3.2 years
November 16, 2022
April 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Evaluation of change of alveolar ridge width on CBCT
at baseline and 6 months postoperatively
Evaluation of change of alveolar ridge height on CBCT
at baseline and 6 months postoperatively
Evaluation of change of alveolar ridge volume on CBCT
at baseline and 6 months postoperatively
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.
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.
- +2 more secondary outcomes
Study Arms (3)
socket seal group
ACTIVE COMPARATORAfter tooth extraction a soft tissue pounch is sutured above the extraction socket.
XSD+ socket seal group
EXPERIMENTALAfter 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.
XSD+ ATB+socket seal group
EXPERIMENTALAfter 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.
Interventions
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 .
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University Department of Periodontology
Budapest, 1088, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Balint Molnar
Department of Periodontology,Semmelweis University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
November 16, 2022
First Posted
January 6, 2023
Study Start
September 1, 2022
Primary Completion
November 30, 2025
Study Completion
December 30, 2025
Last Updated
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share