Efficacy of Socket Grafting for Alveolar Ridge Preservation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Iowa
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01794806
First received: January 22, 2013
Last updated: February 27, 2014
Last verified: February 2014
  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 Phase
Atrophy of Edentulous Alveolar Ridge
Procedure: Tooth extraction and grafting with allograft
Procedure: Tooth extraction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Iowa:

Primary Outcome Measures:
  • Alveolar ridge volumetric changes [ Time Frame: Baseline Week 16 after tooth extraction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in bucco-lingual ridge dimension [ Time Frame: Week 16 after tooth extraction ] [ Designated as safety issue: No ]
  • Changes in apico-coronal ridge dimension [ Time Frame: Week 16 after tooth extraction ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794806

Contacts
Contact: Lauren T Hughes, CNA 319-335-7377 lauren-t-hughes@uiowa.edu
Contact: Mitchell Gubler, DDS mitchell-gubler@uiowa.edu

Locations
United States, Iowa
University of Iowa College of Dentistry - Craniofacial Clinical Research Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lauren T Hughes, CNA    319-335-7377    lauren-t-hughes@uiowa.edu   
Principal Investigator: Gustavo Avila-Ortiz, DDS, MS, PhD         
Sub-Investigator: Mitchell Gubler, DDS         
Sub-Investigator: Christopher Barwacz, DDS, FAGD         
Sub-Investigator: Satheesh Elangovan, BDS DSc DMSc         
Sub-Investigator: Veeratrishul Allareddy, BDS, MS         
Sub-Investigator: Clark Stanford, DDS, PhD         
Sub-Investigator: Deborah Dawson, BS, ScM         
Sub-Investigator: Derek Blanchette, BA, MS         
Sponsors and Collaborators
University of Iowa
Osteogenics Biomedical
Investigators
Principal Investigator: Gustavo Avila-Ortiz, DDS, MS, PhD UI College of Dentistry
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01794806     History of Changes
Other Study ID Numbers: UIOWA-OG-001
Study First Received: January 22, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mouth, Edentulous
Atrophy
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014