Calcium Hydroxylapatite for Receding Gums and Tooth Sensitivity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American Academy of Facial Esthetics

Must not be taking: Antiplatelets, Anticoagulants, Aspirin

Disqualifiers: Uncontrolled systemic disease, Pregnancy, Alcohol or drug abuse, Severe allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of calcium hydroxylapatite (CaHA) injections to treat receding gums and tooth sensitivity. The aim is to determine if these injections can improve gum health and reduce discomfort from sensitive teeth caused by exposed roots. Suitable candidates for this trial have mild to moderate gum recession, no active gum disease, and experience tooth sensitivity. As an unphased trial, participants contribute to innovative research that may lead to new solutions for gum health and tooth sensitivity.

Do I need to stop my current medications for the trial?

If you are taking medications that increase the risk of bleeding, like antiplatelet therapy, anticoagulants, or aspirin, you will need to stop them for a 7-day period before joining the trial. For other medications, the protocol does not specify if you need to stop them.

What prior data suggests that calcium hydroxylapatite is safe for treating receding gums and tooth sensitivity?

Research shows that calcium hydroxylapatite (CaHA) helps with receding gums and sensitive teeth. Studies have found that CaHA is usually well-tolerated in dental treatments, with no major safety concerns reported by participants. However, individuals with a history of allergic reactions to dental materials should exercise caution. Overall, past research suggests the treatment is safe, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for receding gums and tooth sensitivity, such as scaling, root planing, or gum grafts, Calcium Hydroxylapatite offers a unique approach by using targeted injections. Researchers are excited because this treatment involves injecting Radiesse+, a formulation of Calcium Hydroxylapatite, directly into areas around the teeth. This technique potentially provides a more direct and less invasive way to rebuild gum tissue and reduce sensitivity, offering a novel mechanism to enhance gum health and comfort.

What evidence suggests that calcium hydroxylapatite is effective for receding gums and tooth sensitivity?

Research has shown that calcium hydroxylapatite (CaHA), which participants in this trial will receive, can effectively address receding gums and tooth sensitivity. One study demonstrated that CaHA improved gum recession for up to 12 months. Another study found that it significantly reduced tooth sensitivity, with patients reporting less tooth pain after receiving a CaHA injection. These findings suggest that CaHA could be a promising option for enhancing gum health and reducing tooth pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Dr. Louis Malcmacher, DMD

Principal Investigator

American Academy of Facial Esthetics

Are You a Good Fit for This Trial?

This trial is for individuals with gum recession and tooth hypersensitivity. Participants should not have a history of allergic reactions to dental materials, specifically calcium hydroxylapatite (CaHA).

Inclusion Criteria

I am between 20 and 70 years old.

Written informed consent has been obtained

Written authorization for Use and Release of Health and Research Study Information has been obtained

Exclusion Criteria

I have no active mouth infections, cancerous lesions, or unhealed wounds.

History of severe allergic reactions or allergy to numbing agents

I have an infection where I receive my injections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Radiesse(+) injections to treat gingival recession and hypersensitivity

3 months

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Hydroxylapatite

Trial Overview The study tests the effectiveness of Radiesse(+) injections, which contain CaHA, in improving gum health and reducing tooth sensitivity due to exposed roots from receding gums.

How Is the Trial Designed?

Group I: Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity Experimental Treatment 1 Intervention

* The dentist determines the tooth/teeth to be treated, the patient will receive injections of a numbing agent to numb the gums. * Once the patient is numb, he/she will be injected with Radiesse+ on each affected tooth/teeth and one additional tooth on each side of affected tooth/teeth in approximately 5 injection sites per affected tooth in the following locations: papilla (gum between two teeth), halfway between papilla and apex, apex, halfway between papilla on the other side of the tooth and apex, and the second papilla.

Who Is Running the Clinical Trial?

American Academy of Facial Esthetics

Lead Sponsor

Trials

1

Recruited

500+

Merz North America, Inc.

Industry Sponsor

Trials

67

Recruited

10,000+

Leonard Paolillo

Merz North America, Inc.

Chief Executive Officer

Bachelor of Science in Business Administration from Manhattan College

Dr. McKinnon

Merz North America, Inc.

Chief Medical Officer since 2024

Ph.D. in Pharmacology and Toxicology from the University of Western Ontario

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06826391?cond=Periodontal+Diseases

Using Calcium Hydroxylapatite To Treat Gum Recession ... CaHA has recently been shown to improve gum recession with results that lasted 6 months and up to 12 months6, as well as resulted in a reduction in gum ...

2. ctv.veeva.com ctv.veeva.com/study/using-calcium-hydroxylapatite-to-treat-gum-recession-and-tooth-hypersensitivity

Using Calcium Hydroxylapatite to Treat Gum Recession and ... This study will utilize calcium hydroxylapatite (CaHA) to treat recession and hypersensitivity of the gums.

3. withpower.com withpower.com/trial/calcium-hydroxylapatite-for-receding-gums-and-tooth-sensitivity-99b78

Calcium Hydroxylapatite for Receding Gums and Tooth ... Research shows that products containing calcium hydroxyapatite can effectively reduce tooth sensitivity, as seen in studies where it significantly decreased ...

4. researchgate.net researchgate.net/publication/380137344_The_effectiveness_of_calcium_hydroxylapatite-based_Implant_in_eliminating_increased_sensitivity_of_teeth

The effectiveness of calcium hydroxylapatite-based Implant ... RESULTS: Dental hypersensitivity after a single injection of the Radiesse implant steadily decreases compared to its initial values. CONCLUSIONS: Dental ...

5. semanticscholar.org semanticscholar.org/paper/The-effectivnes-of-Radiesse-in-dental-practice-for-Shalak-Satygo/ff4981585299c750da6c84a7cac40585590d0f61

The effectivnes of Radiesse in dental practice for ... Gingival recession after two injections of a Radiesse filler steadily decreases compared to its initial values, and in the absence of treatment, ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06826391/using-calcium-hydroxylapatite-to-treat-gum-recession-and-tooth-hypersensitivity?activelyRecruiting=false&page=41&id=3&slug=acute-and-chronic-dental-pain

Using Calcium Hydroxylapatite to Treat Gum Recession ... Study Purpose and Objectives: This study will utilize calcium hydroxylapatite (CaHA) to treat recession and hypersensitivity of the gums.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4944726/

Gingival recession: its causes and types, and the ... Gingival recession has direct causes and predisposing factors. Orthodontic treatment is able to prevent recession and even contribute to its treatment.