Clinical trial NCT07001345: Alveolar Ridge Preservation Versus Spontaneous Healing
Official title: Alveolar Ridge Preservation (ARP) Versus Spontaneous Healing in Large Buccal Bone Defects After Tooth Extraction in the Posterior Mandible
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implants, Single-tooth
Alveolar Ridge Preservation
Guided Bone Regeneration
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

Eligibility 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 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)

Primary outcomes:
measure: The frequency of additional bone augmentation at implant placement.
timeFrame: During implant placement
Secondary outcomes:
measure: Implant survival
timeFrame: From the moment of implant placement until 10 years of loading
measure: Profilometric outcome measure
timeFrame: after intake, extraction, implant placement, placement of the final crown (after 2 weeks, 1 year, 3 years, 5 years and 10 years)
measure: Prosthetic success
timeFrame: from placement of the final crown until 10 years of loading
measure: Histological outcome measures
timeFrame: After implant placement
measure: Subjective Clinician-reported outcome measures related to the clinician's perception
timeFrame: After the surgical procedures (extraction and implant placement)
measure: PROMS
timeFrame: at intake, after extraction, after implant placement, and 2 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown
measure: Chair Time
timeFrame: At all surgical procedures (extraction, ARP, implant placement)
measure: Costs
timeFrame: After 10 years of loading
measure: Implant success
timeFrame: From one year after implant placement until 10 years of loading
measure: Keratinized mucosal width (KMW)
timeFrame: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown.
measure: Pocket probing depth (PPD)
timeFrame: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown
measure: Bleeding on probing (BOP)
timeFrame: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown
measure: Surgical complications (swelling, dehiscence, haemorrhage, infection)
timeFrame: 2 weeks post extraction and implant placement
measure: Marginal bone levels (MBL)
timeFrame: Post implant placement and 1, 3, 5 and 10 years after placement of the final crown.
measure: Volumetric changes of the bone
timeFrame: after extraction, before implant placement, 1 year, 3 years, 5 years and 10 years after placement of the final crown
measure: Orofacial Esthetic Scale (OES-NL)
timeFrame: 2-4 weeks after placement, and 1, 3, 5 and 10 years after loading of the final crown
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: J. Pijpe, Dr., MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
citation: Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
citation: Monje A, Roccuzzo A, Buser D, Wang HL. Influence of buccal bone wall thickness on the peri-implant hard and soft tissue dimensional changes: A systematic review. Clin Oral Implants Res. 2023 Sep;34 Suppl 26:8-27. doi: 10.1111/clr.14177.
citation: Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.
citation: Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
citation: Jonker BP, Strauss FJ, Naenni N, Jung RE, Wolvius EB, Pijpe J. Early implant placement with or without alveolar ridge preservation in single tooth gaps renders similar esthetic, clinical and patient-reported outcome measures: One-year results of a randomized clinical trial. Clin Oral Implants Res. 2021 Sep;32(9):1041-1051. doi: 10.1111/clr.13796. Epub 2021 Jul 3.
citation: Atieh MA, Alnaqbi M, Abdunabi F, Lin L, Alsabeeha NHM. Alveolar ridge preservation in extraction sockets of periodontally compromised teeth: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Sep;33(9):869-885. doi: 10.1111/clr.13975. Epub 2022 Jul 21.
citation: Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.