Alveolar Ridge Preservation Versus Spontaneous Healing

NCT07001345 | Not Yet Recruiting

• 1 other identifier: NL-009366
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  During implant placement

Secondary Outcomes (16)

• Implant survival

  From the moment of implant placement until 10 years of loading

• Profilometric outcome measure

  after intake, extraction, implant placement, placement of the final crown (after 2 weeks, 1 year, 3 years, 5 years and 10 years)

• Prosthetic success

  from placement of the final crown until 10 years of loading

• Histological outcome measures

  After implant placement

• Subjective Clinician-reported outcome measures related to the clinician's perception

  After the surgical procedures (extraction and implant placement)

Study Arms (3)

ARP with xenograft

EXPERIMENTAL

ARP with xenograft (Cerabone ® plus, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).

Procedure: Alveolar Ridge Reconstruction

ARP with allograft

EXPERIMENTAL

ARP with a freeze dried bone allograft (Maxgraft®, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).

Procedure: Alveolar Ridge Reconstruction

Spontaneous healing

NO INTERVENTION

spontaneous healing and delayed implant placement (4-6 months after tooth extraction).

Interventions

Alveolar Ridge Reconstruction PROCEDURE

Alveolar ridge preservation with either xenograft of allograft material

ARP with allograft; ARP with xenograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 32050833 BACKGROUND

• 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. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

• 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.

  PMID: 37750522 BACKGROUND

• 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.

  PMID: 5224784 BACKGROUND

• 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.

  PMID: 19929956 BACKGROUND

• 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.

  PMID: 34129708 BACKGROUND

• 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.

  PMID: 35818637 BACKGROUND

• 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.

  PMID: 31215112 BACKGROUND

Study Officials

• J. Pijpe, Dr., MD, DDS

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. Jue

CONTACT

(010) 704 01 27; a.jue@erasmusmc.nl

Anouck Jue

CONTACT

+31627872898; a.jue@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)