Insufficient alveolar bone in the mandible
Conditions
Interventions
Intake
Patients will be seen by an experienced surgeon (JP) and a treatment plan will be set up in close cooperation with the referring dentist. Before the surgical procedure, a periapical x-ray pictu
ExtractionPre-operative protocol consists of 2g amoxicillin 1 hour pre-operative according to the clinical guideline. A-traumatic flapless extraction by an experienced surgeon (JP) using elevators and
The measurements will be performed in three dimensions (Figure 1): 
Buccal bone height (a) 
The height from the most apical part of the alveole to the most coronal part of the alveoleWidth in mesiodistal direction (b)The width from the mesial crest to the distal crestWidth in buccolingual di
Patients will be included it there is >
50% buccal height bone loss 
Randomization to either the XG-group, AG-group or control group will take place.In the XG-groep, ARP is performed by using a XG (Cerabone® plus, botiss biomaterials GmbH, Zossen, Germany) and coverage
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 implantAt least one adjacent tooth A buccal bone defect after extraction of 50% or more
Exclusion criteria
Exclusion criteria: Active periodontal diseaseUncontrolled diabetes mellitusHistory of or current chemotherapy or radiation in the head and neck areaHistory of or current use of medication related to osteonecrosis of the jawHeavy and moderate smokers (>5 cigarettes a day) Unable to maintain basic oral health (physical and/or mental)Pregnancy (in case of pregnancy, the treatment is postponed until after the delivery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the frequency of additional bone augmentation at implant placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Clinician-reported outcome measuresImplant survivalImplant successKeratinized mucosal width (KMW) Pocket probing depth (PPD) Bleeding on probing (BOP)Surgical complications (swelling, dehiscence, haemorrhage, infection) RadiographicMarginal bone levels (MBL)Volumetric changes of the boneProfilometricVolumetric changes of the soft tissueEstheticSee PROMsTechnicalProsthetic successHistologicalHistological analysisMicro-computed tomography (µCT) analysisSubjective Clinician-reported outcome measures related to the clinician’s perceptionClinician questionnaire using an 11-point numeric scale assessing difficulty of the procedurePROMSPatient questionnaire based on a VAS score (0-10) assessing satisfaction, pain, swelling and impact of the surgeryOrofacial Esthetic Scale (OES-NL) assessing the esthetics of the tooth Chair TimeChair time in minutesCostsCosts in euros | — |
Countries
Netherlands
Contacts
Public ContactA Jue
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed