Mode
Text Size
Log in / Sign up
N/A N=59 Randomized Single-blind Treatment

Efficacy of Socket Grafting for Alveolar Ridge Preservation

Atrophy of Edentulous Alveolar Ridge

Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Alveolar Ridge Volumetric Changes — -8.36; -15.83 percentage of volume change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tooth extraction and grafting with allograft (Procedure); Tooth extraction (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Iowa
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Alveolar Ridge Volumetric Changes
-8.36; -15.83
SECONDARY
Changes in Bucco-lingual Ridge Dimension
-1.0; -1.8
SECONDARY
Changes in Apico-coronal Ridge Dimension
-0.61; -1.17

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.

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01794806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search