Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity (NCT06826391) | Clinical Trial Compass
By InvitationNot Applicable
Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity
United States500 participantsStarted 2025-02-01
Plain-language summary
Study Purpose and Objectives:
This study will utilize calcium hydroxylapatite (CaHA) to treat recession and hypersensitivity of the gums.
The objectives of the study are:
1. to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue;
2. to determine the efficacy of Radiesse(+) in the reduction of tooth hypersensitivy caused by exposed roots relating to gingival recession;
3. to determine the efficacy of Radiesse(+) in the treatment of mild and moderate gingival recession.
Who can participate
Age range
20 Years – 70 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:
* • Patient selection criteria will be limited to male or female patients between the ages of 20-70 years old.
* Patient must be in good medical health
* Patient has no active periodontal gum disease or inflammation of the gums
* Has thin or intermediate gum collar around the teeth
* Has mild to moderate gum recession as determined by the AAFE Gingival Recession Classification
* Tooth/teeth to be treated for this study to include teeth numbers 5 - 12 and 21 - 28 (see image below)
* Written informed consent has been obtained
* Written authorization for Use and Release of Health and Research Study Information has been obtained
* Ability to follow study instructions and likely to complete all required visits
* If the subject is female of childbearing potential (sexually active and not sterile, surgically sterilized, or postmenopausal with no menses for a least 1 year), the subject has used contraception for at least 30 days prior to enrollment and agrees to use a reliable method of contraception (birth control pills, has an intrauterine device (IUD), and/or condoms) for the duration of the study.
Exclusion Criteria:
* • Uncontrolled systemic disease
* Known allergy or sensitivity to the study medication or its components
* Females who are pregnant, nursing, or planning a pregnancy
* Current enrollment in another investigational drug or device study or participation in such a study within 30 days of entry into this study and for th…
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
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
Timeframe: 3 months
2
Change from Baseline Of Tooth Hypersensitivity With Calcium Hydroxylapatite Injections In Attached Gingiva