Alveolar Ridge Preservation Versus Spontaneous Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
Rationale: To determine the effect of alveolar ridge preservation (ARP) versus spontaneous healing (SH) in large buccal bone defects in the posterior mandible.
Objective: To evaluate whether ARP using a xenograft (XG) (Cerabone plus) or an allograft (AG) (Maxgraft granules) covered by a membrane (Jason membrane) reduces the need for additional bone augmentation either prior to or during implant placement in the posterior mandible compared to spontaneous healing Study design: Prospective randomized clinical study with 10-year follow-up.
Study population:
Inclusion criteria: patients are 18 years or older and in need for extraction of a (pre)molar in the posterior mandible with at least one adjacent tooth and a buccal bone defect of \>50%.
Exclusion criteria: the presence of active periodontal disease, uncontrolled diabetes mellitus, a history of or current use of chemotherapy or radiation in the head and neck area, history of or current use of medication related to osteonecrosis of the jaw, smoking (\> 5 cigarettes a day, disability (physical and/or mental), making the patient unable to maintain basic oral health or follow the study protocol, pregnancy (in case of pregnancy, the treatment is postponed until after the delivery).
Intervention (if applicable): Atraumatic extraction of a (pre)molar in the posterior mandible will be performed. Patients will then be included based on the dimensions of the buccal bone defect (buccal bone defect of \>50%). 66 patients will be randomly divided in either the XG group, the AG group or the SH group (control). In the ARP groups (XG and AG), following tooth extraction, ARP will be performed using either a XG (Cerabone plus) or an AG (Maxgraft granules), both covered by a membrane (Jason membrane). In the control group, the alveolus will be left for spontaneous healing, following tooth extraction. After 4-6 months, a cone bean computed tomography (CBCT) scan will be performed to determine the possibility of implant placement with or without additional augmentation. Implant placement will be performed in all groups with or without guided bone regeneration (GBR).
Main study parameters/endpoints: Frequency of additional augmentation at implant placement.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A minimum age of 18 years old
In need for extraction of a single (pre)molar in the mandible that needs to be replaced by an implant
At least one adjacent tooth
A buccal bone defect after extraction of 50% or more
Disqualifiers
Active periodontal disease
Uncontrolled diabetes mellitus
History of or current chemotherapy or radiation in the head and neck area
History of or current use of medication related to osteonecrosis of the jaw
Trial design
Design model
Parallel
Treatments tested in this trial
Alveolar Ridge Reconstruction
Procedure/SurgeryAlveolar ridge preservation with either xenograft of allograft material
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: ARP with xenograftExperimental treatment 1 intervention
Group B: ARP with allograftExperimental treatment 1 intervention
Group C: Spontaneous healingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The frequency of additional bone augmentation at implant placement.
The frequency of additional bone augmentation at implant placement will be assessed during implant placement.
Time frame
During implant placementSecondary outcomes
1
Implant survival
Implant survival is achieved if there is no presence of any mobility of the individual implant and/or any situation dictating implant removal.
Time frame
From the moment of implant placement until 10 years of loading2
Profilometric outcome measure
Volumetric changes of the soft tissue
Time frame
after intake, extraction, implant placement, placement of the final crown (after 2 weeks, 1 year, 3 years, 5 years and 10 years)3
Prosthetic success
Prosthetic complications will be scored based on the modified United States Public Health Services (USPHS) criteria assessing framework fracture, veneering fracture, occlusal wear, marginal adaptation, anatomical form, cementation gap and patient satisfaction (Bayne \& Schmalz, 2005). Suprastructures scoring delta will be scored as a failure. A suprastructure is scored as successful if all aspects scored only in the alpha or bravo categories (Pol et al., 2022).
Time frame
from placement of the final crown until 10 years of loading4
Histological outcome measures
Histological analysis Micro-computed tomography (μCT) analysis
Time frame
After implant placementSponsors and contacts
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Source ClinicalTrials.gov
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