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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 belowSelect...
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:Select...
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
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
Find a Location
Closest Location:American Academy of Facial Esthetics· South Euclid, OH· 906 miles
Who is running the clinical trial?
American Academy of Facial EstheticsLead Sponsor
Merz North America, Inc.Industry Sponsor
66 Previous Clinical Trials
9,533 Total Patients Enrolled
Dr. Louis Malcmacher, DMDPrincipal InvestigatorAmerican Academy of Facial Esthetics