Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity

NCT06826391 | Enrolling By Invitation FDA Device

• 1 other identifier: 001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue;
2. 2.to determine the efficacy of Radiesse(+) in the reduction of tooth hypersensitivy caused by exposed roots relating to gingival recession;
3. 3.to determine the efficacy of Radiesse(+) in the treatment of mild and moderate gingival recession.

Conditions

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

Keywords

Gingival recession; Tooth sensitivity; Recessed gums; Gum recession; Attached gingiva; Attached gingiva deficiency

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Study Arms (1)

Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity

EXPERIMENTAL

* 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

Interventions

Calcium hydroxylapatite DEVICE

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.

Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• American Academy of Facial Esthetics: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

American Academy of Facial Esthetics

South Euclid, Ohio, 44121, United States

Location

Related Publications (10)

• Roccuzzo M, Bunino M, Needleman I, Sanz M. Periodontal plastic surgery for treatment of localized gingival recessions: a systematic review. J Clin Periodontol. 2002;29 Suppl 3:178-94; discussion 195-6. doi: 10.1034/j.1600-051x.29.s3.11.x.

  PMID: 12787218 BACKGROUND

• Nieri M, Pini Prato GP, Giani M, Magnani N, Pagliaro U, Rotundo R. Patient perceptions of buccal gingival recessions and requests for treatment. J Clin Periodontol. 2013 Jul;40(7):707-12. doi: 10.1111/jcpe.12114. Epub 2013 May 13.

  PMID: 23668251 BACKGROUND

• Renkema AM, Fudalej PS, Renkema A, Bronkhorst E, Katsaros C. Gingival recessions and the change of inclination of mandibular incisors during orthodontic treatment. Eur J Orthod. 2013 Apr;35(2):249-55. doi: 10.1093/ejo/cjs045. Epub 2012 Jul 24.

  PMID: 22828081 BACKGROUND

• Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.

  PMID: 19722789 BACKGROUND

• Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.

  PMID: 3902907 BACKGROUND

• Shalak OV, Satygo EA. The effectiveness of calcium hydroxylapatite-based implant in eliminating increased sensitivity of teeth. Herald of North-Western State Medical University named after I.I. Mechnikov. 2024;16(1):79-86

  BACKGROUND

• Shalak OV, Satygo EA, Deev RV, Presnyakov EV. The efficacy of Radiesse(+) in dental practice for prevention and non-surgical treatment of gingival recession. Herald of North-Western State Medical University named after I.I. Mechnikov. 2022;14(4):43-52.

  BACKGROUND

• 5. Shawky HA, Darwish MM. Clinical application of Radiesse(+) and hyaluronic acid gel for treatment of papillae deficiencies in the esthetic zone. Egyptian Dental J. 2017;63:533-545.

  BACKGROUND

• Loe H, Anerud A, Boysen H. The natural history of periodontal disease in man: prevalence, severity, and extent of gingival recession. J Periodontol. 1992 Jun;63(6):489-95. doi: 10.1902/jop.1992.63.6.489.

  PMID: 1625148 BACKGROUND

• Mythri S, Arunkumar SM, Hegde S, Rajesh SK, Munaz M, Ashwin D. Etiology and occurrence of gingival recession - An epidemiological study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):671-5. doi: 10.4103/0972-124X.156881.

  PMID: 26941519 BACKGROUND

Related Links

• Causes and treatments for gum recession

MeSH Terms

Conditions

Gingival Recession; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Tooth Diseases

Study Officials

• Dr. Louis Malcmacher, DMD

  American Academy of Facial Esthetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 14, 2025
• Study Start: February 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)