NCT01794806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

August 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

January 22, 2013

Results QC Date

March 1, 2017

Last Update Submit

July 8, 2017

Conditions

Atrophy of Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to Week 14 after tooth extraction

Secondary Outcomes (2)

  • Changes in Bucco-lingual Ridge Dimension

    Baseline to Week 14 after tooth extraction

  • Changes in Apico-coronal Ridge Dimension

    Week 14 after tooth extraction

Study Arms (2)

Tooth extraction and grafting

EXPERIMENTAL

Tooth extraction and grafting with allograft

Procedure: Tooth extraction and grafting with allograft

Tooth extraction

SHAM COMPARATOR

Tooth extraction

Procedure: Tooth extraction

Interventions

Tooth extraction and grafting with allograftPROCEDURE

Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane

Also known as: Alveolar socket grafting
Tooth extraction and grafting
Tooth extractionPROCEDURE

Minimally traumatic single-rooted tooth extraction

Tooth extraction

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa College of Dentistry - Craniofacial Clinical Research Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

    PMID: 32050833DERIVED

MeSH Terms

Interventions

Tooth ExtractionTransplantationTransplantation, Homologous

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Results Point of Contact

Title
Gustavo Avila-Ortiz
Organization
University of Iowa
gustavo-avila@uiowa.edu
3193357241

Study Officials

  • Gustavo Avila-Ortiz, DDS, MS, PhD

    UI College of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2013

First Posted

February 20, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 17, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-07

Locations

US(1)