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Alveolar Ridge Preservation Versus Spontaneous Healing

Alveolar Ridge Preservation (ARP) Versus Spontaneous Healing in Large Buccal Bone Defects After Tooth Extraction in the Posterior Mandible

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07001345
Acronym
ARP versus SH
Enrollment
66
Registered
2025-06-03
Start date
2025-06-01
Completion date
2035-06-01
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed description

Extraction of the teeth in the posterior region of the mandible may be an indication for the placement of dental implants. However, after extraction of the teeth, the alveolar ridge undergoes changes due to resorption. Resorption is most pronounced on the buccal side and might complicate implant placement as is could lead to proximity issues with the inferior alveolaris nerve of the mandible. Alveolar ridge preservation (ARP) is commonly performed technique aimed at preserving available bone after tooth extraction. It facilitates delayed implant placement, reducing morbidity and providing optimal esthetic outcomes for implant placement. This procedure is performed using autogenous bone grafts, bone substitutes such as xenografts or allografts or a mixture of both. Also, membranes can be used to direct the growth of new bone. A thin buccal bone wall is an indicator for bone loss that may compromise the integrity of the buccal bone and lead to biologic and esthetic complications. When the buccal bone wall has a width of \< 1.5mm, it is considered an indication for ARP. ARP is found to be effective in reducing bone loss and facilitating implant placement after extraction in the anterior region and for multi-rooted sides. However, most available evidence including RCTs, involves patients with at least 50% of buccal bone intact. Consequently, it is uncertain whether the efficacy ARP is also applicable in situations involving damaged sockets (buccal bone loss \>50%).

Interventions

Alveolar ridge preservation with either xenograft of allograft material

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 implant * At least one adjacent tooth * A buccal bone defect after extraction of 50% or more

Exclusion criteria

* 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 * Heavy 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

MeasureTime frameDescription
The frequency of additional bone augmentation at implant placement.During implant placementThe frequency of additional bone augmentation at implant placement will be assessed during implant placement.

Secondary

MeasureTime frameDescription
Profilometric outcome measureafter intake, extraction, implant placement, placement of the final crown (after 2 weeks, 1 year, 3 years, 5 years and 10 years)Volumetric changes of the soft tissue
Prosthetic successfrom placement of the final crown until 10 years of loadingProsthetic 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).
Histological outcome measuresAfter implant placementHistological analysis Micro-computed tomography (μCT) analysis
Subjective Clinician-reported outcome measures related to the clinician's perceptionAfter the surgical procedures (extraction and implant placement)Clinician questionnaire using an 11-point numeric scale assessing difficulty of the procedure. The lowest score is 0 which indicates extremely easy, the highest score is 10 which indicates extremely hard.
PROMSat intake, after extraction, after implant placement, and 2 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crownPatient questionnaire based on a visual analog scales (VAS) score (0-10) assessing participant satisfaction evaluation during the study will be evaluated that will focus on satisfaction and impact of the surgical procedure and the aesthetic and functional result of the final crown. Score 0 indicates 'least agree' and score 10 indicates 'fully agree'.
Chair TimeAt all surgical procedures (extraction, ARP, implant placement)Chair time in minutes
CostsAfter 10 years of loadingCosts in euros
Implant survivalFrom the moment of implant placement until 10 years of loadingImplant survival is achieved if there is no presence of any mobility of the individual implant and/or any situation dictating implant removal.
Keratinized mucosal width (KMW)1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown.The width of the attached mucosa on the buccal side measured in the middle of the crown
Pocket probing depth (PPD)1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crownThe distance between the marginal gingival border and the tip of the pocket probe inserted against the implant (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal)
Bleeding on probing (BOP)1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crownDichotomously (yes/no) at the mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal side of the implant.
Surgical complications (swelling, dehiscence, haemorrhage, infection)2 weeks post extraction and implant placementswelling (0= no visible oedema, 1 =slight oedema, 2= moderate oedema, 3= severe oedema), mucosal dehiscence (no dehiscence /small dehiscence of less than 2 mm/extensive dehiscence of more than 2mm) haemorrhage (absent/present) and infection (absent/present).
Marginal bone levels (MBL)Post implant placement and 1, 3, 5 and 10 years after placement of the final crown.Changes in marginal bone level
Volumetric changes of the boneafter extraction, before implant placement, 1 year, 3 years, 5 years and 10 years after placement of the final crownVolumetric changes of the bone in percentage
Orofacial Esthetic Scale (OES-NL)2-4 weeks after placement, and 1, 3, 5 and 10 years after loading of the final crownOrofacial Esthetic Scale in Dutch(OES-NL) questionnaire assessing the esthetics of the teeth. Score 0 indicates very unsatisfied and score 10 indicates highly satisfied.
Implant successFrom one year after implant placement until 10 years of loadingAbsence of mobility, absence of persistent subjective complaints (pain, foreign body sensation and/or dysesthesia), absence of recurrent peri-implant infection with suppuration, absence of a continuous radiolucency around the implant, the annual vertical bone loss should not exceed 0.2 mm after the first year of service which should not exceed 1.5 mm, no pocket probing depth (PPD) of 5 mm or more with bleeding on probing (BOP) and no PPD of \>5 mm.

Countries

Netherlands

Contacts

Primary ContactA. Jue
a.jue@erasmusmc.nl(010) 704 01 27
Backup ContactAnouck Jue
a.jue@erasmusmc.nl+31627872898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026