Periodontal Phenotype Study (Tooth Extraction)

Gustavo Avila-Ortiz DDS, MS, PhD

Status: Completed

Conditions: Tooth Extraction Status Nos

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02668289

201510790

Details and patient eligibility

About

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.

Full 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".

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

interventional

Other group

Description:

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

Treatment:

Other: Photographs

Other: Screening

Other: PVS Impressions

Other: consent

Other: Clinical measurements

Other: Anesthesia

Other: CBCT

Procedure: Extraction

Other: Xray