Alveolar Bone Loss
Conditions
Keywords
alveolar ridge preservation, autogenous tooth bone graft, extraction side development technique
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.
Interventions
PROCEDUREExtraction 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 .
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.
PROCEDURESocket 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.
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal ridge width changes | during first surgery and during 6 months reentry | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of change of alveolar ridge width on CBCT | at baseline and 6 months postoperatively | Alveolar ridge width measured at baseline and 6 months postoperatively on CBCT data sets |
| Evaluation of change of alveolar ridge volume on CBCT | at baseline and 6 months postoperatively | Alveolar ridge volumetric changes measured at baseline and 6 months postoperatively on CBCT data sets |
| 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. | Monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging |
| Evaluation of change of alveolar ridge height on CBCT | at baseline and 6 months postoperatively | Alveolar ridge height measured at baseline and 6 months postoperatively on CBCT data sets |
| Soft tissue volumetric changes | analysis of baseline and 6-month post-alveolar digital impressions | Assessment of soft tissue volumetric changes by intraoral scanning |
| Histomorphometry | 6 months postoperatively | 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 |
| 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. | Examination of early wound healing phase by means of clinical photdocumentation |
Countries
Hungary
Contacts
Primary ContactEleonora Solyom, DMD
Backup ContactDaniel Palkovics, DMD
Outcome results
None listed