Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

Launched by AMERICAN ACADEMY OF FACIAL ESTHETICS · Feb 12, 2025

Keywords

ClinConnect Summary

This study is testing whether injections of calcium hydroxylapatite (CaHA), sold as Radiesse+ with lidocaine, can help treat gum recession (gums that pull back from the teeth) and reduce tooth sensitivity caused by exposed roots. It will enroll adults aged 20 to 70 who are generally healthy and have mild to moderate gum recession, with no active gum disease. All participants in this study will receive the CaHA treatment in a single-group design (there is no separate comparison group).

If you participate, a dentist will numb your gums and inject CaHA into the attached gum tissue around the treated teeth at several spots. You’ll have follow-up visits to measure changes in how far the gums cover the tooth roots (0–10 mm) and to rate your tooth sensitivity on a 0–10 scale. The main goal is to see how much the gum recession improves and whether sensitivity decreases over about 3 months. The study is led by the American Academy of Facial Esthetics in South Euclid, Ohio (Dr. Louis Malcmacher as the principal investigator) and is currently enrolling by invitation, with about 500 participants planned. Results aren’t available yet, but researchers may share de-identified study data with approved researchers in the future.

Gender

ALL

Eligibility criteria

• 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 the duration of the study
• • Infection at the injection sites
• • Evidence of recent alcohol or drug abuse
• • Has a history of severe allergic reactions or allergy to numbing agents
• • Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth
• • History of trauma associated with the teeth and/or mouth that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
• • Presence of any clinically significant bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection (subjects being treated with antiplatelet therapy, anticoagulants and acetylsalicylic acid could be enrolled after 7-day washout period
• • Subject has a condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• • Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) or psychiatric disorders (including schizophrenia, bipolar, major depressive, obsessive compulsive, post traumatic stress, borderline personality, panic) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent