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NCT Number: NCT07001345

Alveolar Ridge Preservation Versus Spontaneous Healing

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Alveolar Ridge Reconstruction

Procedure

Alveolar ridge preservation with either xenograft of allograft material

Primary outcomes

  1. The frequency of additional bone augmentation at implant placement.

    Time frame: During implant placement

    The frequency of additional bone augmentation at implant placement will be assessed during implant placement.

Secondary outcomes

  1. Implant survival

    Time frame: From the moment of implant placement until 10 years of loading

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

  2. Profilometric outcome measure

    Time frame: after 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

  3. Prosthetic success

    Time frame: from placement of the final crown until 10 years of loading

    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).

  4. Histological outcome measures

    Time frame: After implant placement

    Histological analysis

    Micro-computed tomography (μCT) analysis

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

    Time frame: After 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.

  6. PROMS

    Time frame: 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

    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'.

  7. Chair Time

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

    Chair time in minutes

  8. Costs

    Time frame: After 10 years of loading

    Costs in euros

  9. Implant success

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

    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.

  10. Keratinized mucosal width (KMW)

    Time frame: 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

  11. Pocket probing depth (PPD)

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

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

  12. Bleeding on probing (BOP)

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

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

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

    Time frame: 2 weeks post extraction and implant placement

    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).

  14. Marginal bone levels (MBL)

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

    Changes in marginal bone level

  15. Volumetric changes of the bone

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

    Volumetric changes of the bone in percentage

  16. Orofacial Esthetic Scale (OES-NL)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

A. Jue

CONTACT

[email protected]

(010) 704 01 27

Anouck Jue

CONTACT

[email protected]

+31627872898

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: ARP versus SH

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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