Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

Part of paid clinical trials in South Euclid, Ohio.

Sponsor
American Academy of Facial Esthetics
Study ID
NCT06826391
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Calcium hydroxylapatite — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
Feb 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity
    * 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.

Primary Outcome Measure

Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
American Academy of Facial EstheticsSouth EuclidOhio44121-

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By research site
American Academy of Facial Esthetics· South Euclid, OH

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