Periodontal Phenotype Study (Tooth Extraction)
NCT02668289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2022-11-07
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.
Conditions
- Tooth Extraction Status Nos
Interventions
- OTHER
-
consent
At 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.
- OTHER
-
Screening
At the initial screening examination, complete medical and dental history will be obtained to verify eligibility.
- OTHER
-
Xray
each subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites.
- OTHER
-
PVS Impressions
PVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest.
- OTHER
-
Photographs
Intraoral photographs will also be taken and subsequent study visits will be planned.
- OTHER
-
CBCT
The 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.
- OTHER
-
Anesthesia
After appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded.
- PROCEDURE
-
Extraction
After 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.
- OTHER
-
Clinical measurements
Measuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames.
Sponsors & Collaborators
-
Gustavo Avila-Ortiz DDS, MS, PhD
lead OTHER
Principal Investigators
-
Gustavo Avila Ortiz, BSE, DDS · University of Iowa
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2020-06-15
- Completion
- 2020-06-15
Countries
- United States
Study Locations
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