Periodontal Phenotype Study (Tooth Extraction)
- Conditions
- Tooth Extraction Status Nos
- Interventions
- Other: consentOther: ScreeningOther: XrayOther: PVS ImpressionsOther: PhotographsOther: CBCTOther: AnesthesiaProcedure: ExtractionOther: Clinical measurements
- Registration Number
- NCT02668289
- Lead Sponsor
- Gustavo Avila-Ortiz DDS, MS, PhD
- 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.
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description interventional consent consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Photographs consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Screening consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Clinical measurements consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional CBCT consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Anesthesia consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Xray consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional Extraction consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements interventional PVS Impressions consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements
- Primary Outcome Measures
Name Time Method Percentage change in tissue volume - Rank Correlations 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.
- Secondary Outcome Measures
Name Time Method Probing Depths of soft tissue dimensions 14 weeks supracrestal soft tissue dimensions will be evaluated
bone thickness ( facial and lingual) - Correlations 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.
soft tissue thickness (facial and lingual) -correlations 14 weeks correlations among the periodontal phenotype and the supracrestal soft tissue dimensions will be evaluated.
Trial Locations
- Locations (1)
UIowa
🇺🇸Iowa City, Iowa, United States