NCT06826391

Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

Evaluating the Use of Calcium Hydroxylapatite With Integral Lidocaine for Improving Gingival Recession and Hypersensitivity

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: American Academy of Facial Esthetics · Network
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Recession of the gingiva or gums, is a prevalent condition in the U.S. population. Gum recession can start early in life, with \~27% of people 15-25 years experiencing recession. The frequency of gum recession increases with age, with 70.3% of adults 45-60 years and \~100% of adults will experience gum recession in their lifetime. Recession of the gums is defined as the shift of the marginal gingiva from its normal position on the crown of the tooth to the levels on the root surface beyond the cemento-enamel junction. Whereas many dental conditions go unnoticed by patients, gum recession can often be visible to patients and for which they may seek advice of a dentist. Gingival recession of the front teeth usually creates an aesthetic problem and anxiety about tooth loss due to progression of the destruction. Gum recession may also be associated with dentin hypersensitivity, root caries, abrasion and/or cervical wear, erosion because of exposure of the root surface to the oral environment and an increase in accumulation of dental plaque. Gum recession may be caused by a variety of factors, including but not limited to smoking, hormonal changes, genetics, periodontal disease or insufficient dental hygiene. Treatment for gum recession includes a deep cleaning, dental bonding, antibiotics and surgery. Calcium hydroxylappetite (CaHA; Radiesse, Merz Aesthetics, Raleigh, NC) is FDA cleared as a facial implant for volume improvement for moderate to severe wrinkles and folds such as the nasolabial folds. CaHA is also cleared by the FDA to fill and/or augment dental defects, including periodontal defects. Radiesse is composed of synthetically produced, smooth and uniform calcium hydroxide microspheres suspended in carboxymethylcellulose gel in ratio 30% microspheres to 70% gel by volume. Radiesse(+) and is the same formulation as Radiesse with the addition of lidocaine in powder format, which reduces pain of injection. The CaHA in Radiesse/Radiesse(+) is biocompatible and possess a low risk of stimulating an immune response. Studies have shown that CaHA is an effective collagen and elastin stimulator as well as a robust filler for soft tissue augmentation. 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 hypersensivity.

Conditions

• Gingival Recession, Generalized
• Gingival Recession Generalized Moderate
• Gingival Recession Localized Moderate
• Tooth Sensitivity

Interventions

Type	Name	Description
DEVICE	Calcium hydroxylapatite	This intervention consists of calcium hydroxylapatite injections into the attached gingiva of a patient who has gingival recession to stabilize, grow and reverse gingival recession. These injections will also reduce tooth hypersensitivty in the affected teeth.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-02-14
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study