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.

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.

Inclusion Criteria:

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

  • Patient must be in good medical health
  • Patient has no active periodontal gum disease or inflammation of the gums
  • Has thin or intermediate gum collar around the teeth
  • Has mild to moderate gum recession as determined by the AAFE Gingival Recession Classification
  • Tooth/teeth to be treated for this study to include teeth numbers 5 - 12 and 21 - 28 (see image below)
  • Written informed consent has been obtained
  • Written authorization for Use and Release of Health and Research Study Information has been obtained
  • Ability to follow study instructions and likely to complete all required visits
  • If the subject is female of childbearing potential (sexually active and not sterile, surgically sterilized, or postmenopausal with no menses for a least 1 year), the subject has used contraception for at least 30 days prior to enrollment and agrees to use a reliable method of contraception (birth control pills, has an intrauterine device (IUD), and/or condoms) for the duration of the study.

Exclusion Criteria:

• • Uncontrolled systemic disease

  • Known allergy or sensitivity to the study medication or its components
  • Females who are pregnant, nursing, or planning a pregnancy
  • Current enrollment in another investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study
  • Infection at the injection sites
  • Evidence of recent alcohol or drug abuse
  • Has a history of severe allergic reactions or allergy to numbing agents
  • Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth
  • History of trauma associated with the teeth and/or mouth that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
  • Presence of any clinically significant bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection (subjects being treated with antiplatelet therapy, anticoagulants and acetylsalicylic acid could be enrolled after 7-day washout period
  • Subject has a condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) or psychiatric disorders (including schizophrenia, bipolar, major depressive, obsessive compulsive, post traumatic stress, borderline personality, panic) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent

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.

The time frame will be beginning 3 months and ending 3 years after the publication of results

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.