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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
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.
Semmelweis University Department of Periodontology
Budapest, Hungary
RECRUITINGHorizontal 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).
Time frame: during first surgery and during 6 months reentry
Evaluation of change of alveolar ridge width on CBCT
Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets
Time frame: at baseline and 6 months postoperatively
Evaluation of change of alveolar ridge height on CBCT
Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets
Time frame: at baseline and 6 months postoperatively
Evaluation of change of alveolar ridge volume on CBCT
Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets
Time frame: at baseline and 6 months postoperatively
Monitoring the microvascularization
Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging
Time frame: 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
Examination of early wound healing phase by means of clinical photdocumentation
Time frame: Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.
Soft tissue volumetric changes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Assessment of soft tissue volumetric changes by intraoral scanning
Time frame: analysis of baseline and 6-month post-alveolar digital impressions
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
Time frame: 6 months postoperatively