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Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

NCT06826391 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • American Academy of Facial Esthetics

    lead NETWORK

Principal Investigators

  • Dr. Louis Malcmacher, DMD · American Academy of Facial Esthetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-11-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06826391 on ClinicalTrials.gov