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Dental Implants, Single-toothARP versus SHNCT07001345

Alveolar Ridge Preservation Versus Spontaneous Healing

A study testing Alveolar Ridge Reconstruction in people with Dental Implants, Single-tooth and Alveolar Ridge Preservation, run by Erasmus Medical Center at 1 site in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Alveolar Ridge Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteNetherlands
Study dates
1 Jun 2025to 1 Jun 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site
  • Erasmus MC

    Rotterdam, South Holland, 3015GD

    A. Jue, (010) 704 01 27, a.jue@erasmusmc.nl

Other trials in Netherlands

About this study

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

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.

Read more

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.

Read the 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%).

Being tested
Alveolar Ridge Reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alveolar Ridge ReconstructionProcedure or surgery

    Alveolar ridge preservation with either xenograft of allograft material

Study groups in NCT07001345
Study groupRoleWhat they receive
ARP with xenograftExperimentalARP 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).
Receives: Procedure: Alveolar Ridge Reconstruction
ARP with allograftExperimentalARP 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).
Receives: Procedure: Alveolar Ridge Reconstruction
Spontaneous healingNo interventionspontaneous healing and delayed implant placement (4-6 months after tooth extraction).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During implant placement

Secondary outcomes (16)
  1. Implant survival

    Implant survival is achieved if there is no presence of any mobility of the individual implant and/or any situation dictating implant removal.

    Measured: From the moment of implant placement until 10 years of loading

  2. Profilometric outcome measure

    Volumetric changes of the soft tissue

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

  3. Prosthetic success

    Prosthetic 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).

    Measured: from placement of the final crown until 10 years of loading

  4. Histological outcome measures

    Histological analysis

    Micro-computed tomography (μCT) analysis

    Measured: After implant placement

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

    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.

    Measured: After the surgical procedures (extraction and implant placement)

  6. PROMS

    Patient 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'.

    Measured: 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

  7. Chair Time

    Chair time in minutes

    Measured: At all surgical procedures (extraction, ARP, implant placement)

  8. Costs

    Costs in euros

    Measured: After 10 years of loading

  9. Implant success

    Absence 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.

    Measured: From one year after implant placement until 10 years of loading

  10. Keratinized mucosal width (KMW)

    The width of the attached mucosa on the buccal side measured in the middle of the crown

    Measured: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown.

  11. Pocket probing depth (PPD)

    The distance between the marginal gingival border and the tip of the pocket probe inserted against the implant (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal)

    Measured: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown

  12. Bleeding on probing (BOP)

    Dichotomously (yes/no) at the mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, distopalatal side of the implant.

    Measured: 1-4 weeks, 1 year, 3 years, 5 years and 10 years after placement of the final crown

  13. Surgical complications (swelling, dehiscence, haemorrhage, infection)

    swelling (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).

    Measured: 2 weeks post extraction and implant placement

  14. Marginal bone levels (MBL)

    Changes in marginal bone level

    Measured: Post implant placement and 1, 3, 5 and 10 years after placement of the final crown.

  15. Volumetric changes of the bone

    Volumetric changes of the bone in percentage

    Measured: after extraction, before implant placement, 1 year, 3 years, 5 years and 10 years after placement of the final crown

  16. Orofacial Esthetic Scale (OES-NL)

    Orofacial Esthetic Scale in Dutch(OES-NL) questionnaire assessing the esthetics of the teeth. Score 0 indicates very unsatisfied and score 10 indicates highly satisfied.

    Measured: 2-4 weeks after placement, and 1, 3, 5 and 10 years after loading of the final crown

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Jun 2035 (estimated)
  4. Study completion1 Jun 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001345
Sponsor's protocol ID
NL-009366
Acronym
ARP versus SH
Status last verified
May 2025
First submitted
1 May 2025
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32050833
  • 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.

    PubMed 30623987
  • 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.

    PubMed 37750522
  • 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.

    PubMed 5224784
  • 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.

    PubMed 19929956
  • 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.

    PubMed 34129708
  • 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.

    PubMed 35818637
  • 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.

    PubMed 31215112

Questions about this trial

What is this clinical trial studying?

A study testing Alveolar Ridge Reconstruction in people with Dental Implants, Single-tooth and Alveolar Ridge Preservation, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact A. Jue ((010) 704 01 27, a.jue@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency of additional bone augmentation at implant placement. (time frame: During implant placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07001345, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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