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Alveolar Ridge Preservation Versus Spontaneous Healing

NCT07001345 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-06-03

No results posted yet for this study

Summary

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.

Conditions

  • Dental Implants, Single-tooth
  • Alveolar Ridge Preservation
  • Guided Bone Regeneration

Interventions

PROCEDURE

Alveolar Ridge Reconstruction

Alveolar ridge preservation with either xenograft of allograft material

Sponsors & Collaborators

Principal Investigators

  • J. Pijpe, Dr., MD, DDS · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2035-06-01
Completion
2035-06-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001345 on ClinicalTrials.gov