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Completed

NCT Number: NCT02702609

Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System

Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.

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Key information

Conditions

Dental Implants Alveolar Ridge Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Iowa College of Dentistry, Iowa City, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent
  • At least 18 years old
  • In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
  • Intact ridge as verified with cone-beam CT scan
  • At least one natural tooth adjacent to the study site present.

Exclusion criteria

  • Insufficient interocclusal space to allow for implant supported prosthesis
  • Dehiscence or fenestration identified at the time of reviewing CBCT.
  • Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
  • Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
  • Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
  • Adjacent teeth (or tooth) to study site with significant soft tissue loss
  • Smoker using more than 10 cigarettes or equivalent per day
  • Smokeless tobacco use or e-cigarette use
  • Current alcohol or drug abuser
  • Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
  • Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
  • Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
  • Unable or unwilling to return for follow-up visits for a period of 5 months
  • Unlikely to be able to comply with study procedures according to Investigators judgement
  • Subject in other clinical trials

Treatment and study plan

easy-graft CLASSIC

Device

easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.

FDBA with collagen plug

Device

FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.

Primary outcomes

  1. Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)

    Time frame: Baseline and 4 months post-surgery

    Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)

  2. Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)

    Time frame: Baseline and 4 months post-surgery

    Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.

Secondary outcomes

  1. Histomorphometric Assessment of Newly Formed Mineralized Tissue

    Time frame: 5 months post-surgery

    Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of mineralized tissue respective to the percent of the total core area.

  2. Histomorphometric Assessment of Residual Bone Graft Particles

    Time frame: 5 months post-surgery

    Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of residual bone graft respective to the percent of the total core area.

  3. Histomorphometric Assessment of Non-mineralized Tissue

    Time frame: 5 months post-surgery

    Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of non-mineralized tissue respective to the percent of the total core area.

  4. Change of Marginal Bone Level Around Dental Implant

    Time frame: Baseline, 6, and 12 months after crown delivery

    Linear measurement of marginal bone level (MBL) in millimeters along mesial and distal dental implant surface are captured in periapical standardized radiographs at crown delivery (baseline), 6, and 12 months after crown delivery. Change of MBL = (Baseline measurement - 6 or 12 months measurement)

Sponsors and collaborators

Lead sponsor

Sunstar Americas

Industry

Registry information

Official study title

Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2016
Registry last updated
Oct 22, 2020

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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