Periodontal Phenotype Study (Tooth Extraction)

November 4, 2022 updated by: Gustavo Avila-Ortiz DDS, MS, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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) 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

Exclusion Criteria:

  • More than 1 mm of recession present on the tooth planned for extraction and inclusion in the study
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: interventional
consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in tissue volume - Rank Correlations
Time Frame: 14 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depths of soft tissue dimensions
Time Frame: 14 weeks
supracrestal soft tissue dimensions will be evaluated
14 weeks
bone thickness ( facial and lingual) - Correlations
Time Frame: 14 weeks
Analogous correlational approaches, supplemented by regression methods, will be used to assess the relationships between measurements made by CBCT with those derived from volumetric analysis of casts.
14 weeks
soft tissue thickness (facial and lingual) -correlations
Time Frame: 14 weeks
correlations among the periodontal phenotype and the supracrestal soft tissue dimensions will be evaluated.
14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
width of keratinized gingiva
Time Frame: 14 weeks
supracrestal soft tissue dimensions will be evaluated
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustavo Avila-Ortiz DDS, MS, PhD

Investigators

  • Principal Investigator: Gustavo Avila Ortiz, BSE, DDS, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2016

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201510790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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