Clinical Trials Directory

Trials / Completed

CompletedNCT02668289

Periodontal Phenotype Study (Tooth Extraction)

Periodontal Phenotype and Supracrestal Soft Tissue Dimentions - Clinical Correlations and Their Impact on Post-extraction Volumetric Changes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Gustavo Avila-Ortiz DDS, MS, PhD · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults. 65 adult subjects who are in need of dental extractions will be recruited. Clinical measurements will be gathered prior to and immediately following the single tooth extraction. There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for photographic documentation and clinical measurements of the extraction area.

Detailed description

Periodontal phenotype, also known as periodontal biotype, has been recognized as one of the key factors that may potentially impact the outcome of a variety of esthetic restorative procedures. With the increasing esthetic demand of patients in the context of tooth replacement therapy in the anterior esthetic zone, the ability to determine the prognostic value and the influence on treatment outcomes of this parameter has become a critical component of contemporary treatment planning. Periodontal phenotype encompases "bone morphotypes, shapes of the teeth, morphologic characteristics of the gingiva and the periodontium".

Conditions

Interventions

TypeNameDescription
OTHERconsentAt the initial screening examination, each subject will receive an informed consent form. Prior to signing the informed consent, one of the investigators or qualified staff will thoroughly discuss participation in the study with each subject, allocating time for questions and answers.
OTHERScreeningAt the initial screening examination, complete medical and dental history will be obtained to verify eligibility.
OTHERXrayeach subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites.
OTHERPVS ImpressionsPVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest.
OTHERPhotographsIntraoral photographs will also be taken and subsequent study visits will be planned.
OTHERCBCTThe patient will then be sent to the Department of Radiology at the College of Dentistry for a baseline CBCT and follow-up at 14 week CBCT. These CBCT's will be utilized to evaluate the hard tissue volume in comparison to the clinical volume of soft tissue.
OTHERAnesthesiaAfter appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded.
PROCEDUREExtractionAfter the pre-extraction baseline measurements are recorded and adequate anesthesia is confirmed, minimally invasive extraction procedures will be initiated. All extractions will be performed by residents in the UI CoD Periodontics advanced education program.
OTHERClinical measurementsMeasuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames.

Timeline

Start date
2016-01-31
Primary completion
2020-06-15
Completion
2020-06-15
First posted
2016-01-29
Last updated
2022-11-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02668289. Inclusion in this directory is not an endorsement.