Periodontal Phenotype Study (Tooth Extraction)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-06-15

Brief Summary

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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.

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Detailed Description

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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

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Tooth Extraction Status Nos

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interventional

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

Group Type OTHER

consent

Intervention Type 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.

Screening

Intervention Type OTHER

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

Xray

Intervention Type OTHER

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

PVS Impressions

Intervention Type OTHER

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

Photographs

Intervention Type OTHER

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

CBCT

Intervention Type 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.

Anesthesia

Intervention Type OTHER

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

Extraction

Intervention Type 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.

Clinical measurements

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Screening

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

Intervention Type OTHER

Xray

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

Intervention Type OTHER

PVS Impressions

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

Intervention Type OTHER

Photographs

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

Intervention Type 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.

Intervention Type OTHER

Anesthesia

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

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Clinical measurements

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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes