Periodontal Phenotype Study (Tooth Extraction) (NCT02668289) | Clinical Trial Compass
CompletedNot Applicable
Periodontal Phenotype Study (Tooth Extraction)
United States42 participantsStarted 2016-01-31
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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What they're measuring
1
Percentage change in tissue volume - Rank Correlations