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Efficacy of Socket Grafting for Alveolar Ridge Preservation

Primary Purpose

Atrophy of Edentulous Alveolar Ridge

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tooth extraction and grafting with allograft
Tooth extraction
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy of Edentulous Alveolar Ridge

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Iowa College of Dentistry - Craniofacial Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Tooth extraction and grafting

Tooth extraction

Arm Description

Tooth extraction and grafting with allograft

Tooth extraction

Outcomes

Primary Outcome Measures

Alveolar Ridge Volumetric Changes
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
Linear ridge width change at the bone crest
Changes in Apico-coronal Ridge Dimension
Linear ridge height change at the mid-facial aspect of the ridge

Full Information

First Posted
January 22, 2013
Last Updated
July 8, 2017
Sponsor
University of Iowa
Collaborators
Osteogenics Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT01794806
Brief Title
Efficacy of Socket Grafting for Alveolar Ridge Preservation
Official Title
Efficacy of Socket Grafting for Alveolar Ridge Preservation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Osteogenics Biomedical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Alveolar Ridge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tooth extraction and grafting
Arm Type
Experimental
Arm Description
Tooth extraction and grafting with allograft
Arm Title
Tooth extraction
Arm Type
Sham Comparator
Arm Description
Tooth extraction
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction and grafting with allograft
Other Intervention Name(s)
Alveolar socket grafting
Intervention Description
Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction
Intervention Description
Minimally traumatic single-rooted tooth extraction
Primary Outcome Measure Information:
Title
Alveolar Ridge Volumetric Changes
Description
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
Time Frame
Baseline to Week 14 after tooth extraction
Secondary Outcome Measure Information:
Title
Changes in Bucco-lingual Ridge Dimension
Description
Linear ridge width change at the bone crest
Time Frame
Baseline to Week 14 after tooth extraction
Title
Changes in Apico-coronal Ridge Dimension
Description
Linear ridge height change at the mid-facial aspect of the ridge
Time Frame
Week 14 after tooth extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Avila-Ortiz, DDS, MS, PhD
Organizational Affiliation
UI College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa College of Dentistry - Craniofacial Clinical Research Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32050833
Citation
Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
Results Reference
derived

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Efficacy of Socket Grafting for Alveolar Ridge Preservation

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