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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Calcium Hydroxylapatite for receding gums and tooth sensitivity?

Research shows that products containing calcium hydroxyapatite can effectively reduce tooth sensitivity, as seen in studies where it significantly decreased dentin hypersensitivity compared to placebos and other treatments. Additionally, a study found that using a paste and suspension with nano-hydroxyapatite effectively reduced tooth sensitivity in people with receding gums. ^{1 2 3 4 5}

Is calcium hydroxylapatite safe for use in humans?

Calcium hydroxylapatite is generally considered safe for use in humans, with common side effects like swelling and bruising at the injection site, which usually resolve within a week or two. No serious or unexpected adverse events have been reported in studies involving its use for facial and hand volume restoration. ^{1 6 7 8 9}

How does the treatment Calcium Hydroxylapatite for receding gums and tooth sensitivity differ from other treatments?

Calcium Hydroxylapatite is unique because it uses tiny particles to seal the open tubules in teeth, reducing sensitivity by blocking pathways to nerves, which is similar to the natural mineral composition of teeth. This approach is different from conventional treatments that may not mimic the natural tooth structure as closely. ^{1 2 5 10 11}

What is the purpose of this trial?

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.

Research Team

Dr. Louis Malcmacher, DMD

Principal Investigator

American Academy of Facial Esthetics

Eligibility Criteria

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

My treatment involves front teeth numbered 5-12 and 21-28.

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.

I have an infection where I receive my injections.

I have had injuries to my teeth or mouth that could affect treatment results.

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

A clinical study of the efficacy of a new chewing gum containing calcium hydroxyapatite in reducing dentin hypersensitivity. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

[Investigation of utility and mechanics of use of hydroxyapatite for therapy of hypersensitive tooth root]. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Evidence of Biomimetic Hydroxyapatite in Oral Care Products for Reducing Dentin Hypersensitivity: An Updated Systematic Review and Meta-Analysis. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

Biomimetic hydroxyapatite paste for molar-incisor hypomineralization: A randomized clinical trial. [2023]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficiency of paste and suspension with nano-hydroxyapatite on the sensitivity of teeth with gingival recession]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blinded, Sham-Controlled, Split-Hand Trial Evaluating the Safety and Efficacy of Triamcinolone Acetate Injection After Calcium Hydroxylapatite Volume Restoration of the Dorsal Hand. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of injection laryngoplasty using calcium hydroxylapatite. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Calcium Hydroxylapatite for Augmentation of Face and Hands: A Retrospective Analysis in Italian Subjects. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Guidelines for Optimal Patient Outcomes Using Calcium Hydroxylapatite for Jawline Contour. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Mechanism of action of a desensitizing fluoride toothpaste delivering calcium and phosphate ingredients in the treatment of dental hypersensitivity. Part II: comparison with a professional treatment for tooth hypersensitivity. [2016]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of Calcium Phosphates in the Treatment of Dentinal Hypersensitivity: A Systematic Review. [2023]