An interventional study of Calcium hydroxylapatite in Gingival Recession, Generalized, Gingival Recession Generalized Moderate and Gingival Recession Localized Moderate, sponsored by American Academy of Facial Esthetics. Enrolling by invitation at 1 site in United States. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by American Academy of Facial Esthetics · Not applicable, Interventional, and Treatment
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:
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.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 500 is above the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →This is the only study on the registry with American Academy of Facial Esthetics as lead sponsor.
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Patient selection criteria will be limited to male or female patients between the ages of 20-70 years old.
Exclusion Criteria:
Uncontrolled systemic disease
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
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.
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
Gum recession will be measured at baseline, during the study, and at the end of the study for the affected teeth. For gum recession, a dentist will measure the amount of gum recession present at each stage. Gum recession measurements range from 0 -10 mm. 0 means no gum recession and 10 is severe gum recession. Investigators and patients will grade their results based on the Global Aesthetic Improvement Scale (GAIS) as (1) very much improved, (2) much improved, (3) improved, (4) no change. The same doctor will be taking the measurements and administering treatment at each stage to standardize the information in this study.
Time frame: 3 months
Change from Baseline Of Tooth Hypersensitivity With Calcium Hydroxylapatite Injections In Attached Gingiva
Tooth hypersensitivity will be measured at baseline, during the study, and at the end of the study for the affected teeth. Tooth hypersensitivity will be assessed by the patient on a 0-10 scale at each stage of the study. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: 3 months
Plan to share: Yes — Specific individual participant data sets to be shared will include the study protocol, the statisical analysis plan, the informed consent form, adverse reaction form, the clinical study report, analytic codes if any, all collected IPD, and all IPD that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The time frame will be beginning 3 months and ending 3 years after the publication of results
Access criteria: The criteria that will be met in order for data to be shared includes statistical methods which must be approved by independent review. A proposal that describes planned analyses must be submitted. A data sharing agreement must be signed. These documents can be submitted to the Primary Investigator, Dr. Louis Malcmacher, who will review requests for IPD sharing.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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