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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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.
NOT…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage change in tissue volume - Rank Correlations