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Efficacy of Socket Grafting for Alveolar Ridge Preservation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794806
First Posted: February 20, 2013
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
Gustavo Avila-Ortiz, University of Iowa
  Purpose
The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.

Condition Intervention
Atrophy of Edentulous Alveolar Ridge Procedure: Tooth extraction and grafting with allograft Procedure: Tooth extraction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Socket Grafting for Alveolar Ridge Preservation: A Randomized Controlled Trial

Further study details as provided by Gustavo Avila-Ortiz, University of Iowa:

Primary Outcome Measures:
  • Alveolar Ridge Volumetric Changes [ Time Frame: Baseline to Week 14 after tooth extraction ]
    3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups


Secondary Outcome Measures:
  • Changes in Bucco-lingual Ridge Dimension [ Time Frame: Baseline to Week 14 after tooth extraction ]
    Linear ridge width change at the bone crest

  • Changes in Apico-coronal Ridge Dimension [ Time Frame: Week 14 after tooth extraction ]
    Linear ridge height change at the mid-facial aspect of the ridge


Enrollment: 59
Study Start Date: March 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tooth extraction and grafting
Tooth extraction and grafting with allograft
Procedure: Tooth extraction and grafting with allograft
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
Other Name: Alveolar socket grafting
Sham Comparator: Tooth extraction
Tooth extraction
Procedure: Tooth extraction
Minimally traumatic single-rooted tooth extraction

Detailed Description:
Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (tooth extraction alone) or an experimental group (tooth extraction and ridge preservation using an allograft to fill the alveolar socket covered with a non-absorbable, dense polytetrafluoroethylene membrane [dPTFE]). Clinical linear measurements of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent. Following extraction, primary closure of the socket will not be attempted. Subjects will be re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks. Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of the ridge and changes in modified wound healing index changes overtime. The influence of the thickness of the facial and lingual bone of the alveolar ridge and the width of the keratinized tissue on the remodeling of the ridge will be evaluated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18 to 75 years.
  • Gender: No restriction.
  • Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
  • Subjects must be able and willing to follow instructions related to the study procedures.
  • Subjects must have read, understood and signed an informed consent form.

Exclusion Criteria:

  • Reported allergy or hypersensitivity to any of the products to be used in the study.
  • Severe hematologic disorders, such as hemophilia or leukemia.
  • Active severe infectious diseases that may compromise normal healing.
  • Liver or kidney dysfunction/failure.
  • Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
  • Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more).
  • Subjects with a history of IV bisphosphonates.
  • Subjects with uncontrolled diabetes.
  • Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
  • Pregnant women or nursing mothers.
  • Smokers: Subjects who have smoked within 6 months of study onset.
  • Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.

NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.

- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794806


Locations
United States, Iowa
University of Iowa College of Dentistry - Craniofacial Clinical Research Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Osteogenics Biomedical
Investigators
Principal Investigator: Gustavo Avila-Ortiz, DDS, MS, PhD UI College of Dentistry
  More Information

Responsible Party: Gustavo Avila-Ortiz, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01794806     History of Changes
Other Study ID Numbers: 201301766
First Submitted: January 22, 2013
First Posted: February 20, 2013
Results First Submitted: March 1, 2017
Results First Posted: July 11, 2017
Last Update Posted: August 17, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical