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Calcium Hydroxylapatite for Receding Gums and Tooth Sensitivity

South Euclid, OH

N/A

Waitlist Available

Led By Dr. Louis Malcmacher, DMD

Research Sponsored by American Academy of Facial Esthetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient selection criteria limited to male or female patients between the ages of 20-70 years old

Patient has no active periodontal gum disease or inflammation of the gums

Must not have

Active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth

Infection at the injection sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use calcium hydroxylapatite (CaHA) to treat gum recession and hypersensitivity. The study will focus on evaluating the changes in attached gums after injections of Radiesse

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Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, swelling or bruising of the gums, and rare allergic reactions to the components in Radiesse(+).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 70 years old.

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I do not have active gum disease.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have an infection where I receive my injections.

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I have a disease that is not under control.

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I am not pregnant, nursing, or planning to become pregnant.

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I have a bleeding disorder or take medication that increases bleeding risk.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva

Change from Baseline Of Tooth Hypersensitivity With Calcium Hydroxylapatite Injections In Attached Gingiva

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and HypersensitivityExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Calcium hydroxylapatite

2010

Completed Phase 4

~20

0 / 7Eligibility criteria met