Periodontal Phenotype Study (Tooth Extraction)

NCT02668289 | Completed

• 1 other identifier: 201510790
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage change in tissue volume - Rank Correlations

  For the purpose of this study, a 10-20% reduction in the volume must detectable. Pearson correlations will be used to assess associations if appropriate and Spearman rank correlations will be considered if needed.

  14 weeks

Secondary Outcomes (3)

• Probing Depths of soft tissue dimensions

  14 weeks

• bone thickness ( facial and lingual) - Correlations

  14 weeks

• soft tissue thickness (facial and lingual) -correlations

  14 weeks

Other Outcomes (1)

• width of keratinized gingiva

  14 weeks

Study Arms (1)

interventional

OTHER

consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements

Other: consent; Other: Screening; Other: Xray; Other: PVS Impressions; Other: Photographs; Other: CBCT; Other: Anesthesia; Procedure: Extraction; Other: Clinical measurements

Interventions

consent OTHER

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.

interventional

Screening OTHER

At the initial screening examination, complete medical and dental history will be obtained to verify eligibility.

interventional

Xray OTHER

each subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites.

interventional

PVS Impressions OTHER

PVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest.

interventional

Photographs OTHER

Intraoral photographs will also be taken and subsequent study visits will be planned.

interventional

CBCT OTHER

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.

interventional

Anesthesia OTHER

After appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded.

interventional

Extraction PROCEDURE

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.

interventional

Clinical measurements OTHER

Measuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames.

interventional

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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) in the maxillary anterior region (first premolar to first premolar)
• 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, defined as Hba1c \> 7.0
• Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded
• Pregnant women or nursing mothers
• Heavy smokers: Subjects who have smoked \>10 cigarettes per day 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).

Sponsors & Collaborators

• Gustavo Avila-Ortiz DDS, MS, PhD: lead

Study Sites (1)

UIowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Couso-Queiruga E, Graham ZA, Peter T, Gonzalez-Martin O, Galindo-Moreno P, Avila-Ortiz G. Effect of periodontal phenotype characteristics on post-extraction dimensional changes of the alveolar ridge: A prospective case series. J Clin Periodontol. 2023 May;50(5):694-706. doi: 10.1111/jcpe.13781. Epub 2023 Feb 1.

  PMID: 36644815 DERIVED

MeSH Terms

Interventions

Consent Forms; Mass Screening; X-Rays; Moire Topography; Anesthesia

Intervention Hierarchy (Ancestors)

Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health; Environment and Public Health; Public Health Practice; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Photogrammetry; Photography; Diagnostic Imaging; Interferometry; Anesthesia and Analgesia

Study Officials

• Gustavo Avila Ortiz, BSE, DDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: January 31, 2016
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)