Efficacy of Socket Grafting for Alveolar Ridge Preservation

Atrophy of Edentulous Alveolar Ridge Clinical Trial

Official title:

Efficacy of Socket Grafting for Alveolar Ridge Preservation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794806
• Other study ID #: UIOWA-OG-001
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2013
• Last updated: October 21, 2014
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy of Edentulous Alveolar Ridge

Intervention

Procedure:
• Tooth extraction and grafting with allograft
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
• Tooth extraction
Minimally traumatic single-rooted tooth extraction

Locations

Country	Name	City	State
United States	University of Iowa College of Dentistry - Craniofacial Clinical Research Center	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Osteogenics Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar ridge volumetric changes		Baseline Week 16 after tooth extraction	No
Secondary	Changes in bucco-lingual ridge dimension		Week 16 after tooth extraction	No
Secondary	Changes in apico-coronal ridge dimension		Week 16 after tooth extraction	No