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NCT06826391

Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

Enrolling by Invitation
NAAges 20–70InterventionalTreatment
American Academy of Facial Esthetics
~500 participants
Updated 2025-02-17 on ClinicalTrials.gov
What's tested:Calcium hydroxylapatite

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
Measured over 3 months
+1 more outcome measured

Conditions

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

Explore related trials

Attached Gingiva DeficiencyGingival RecessionTooth Sensitivity

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

• 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

• 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

What this trial measures

  • Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva3 months

    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.

  • Change from Baseline Of Tooth Hypersensitivity With Calcium Hydroxylapatite Injections In Attached Gingiva3 months

    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.