Gingival Recession, GeneralizedNCT06826391
Using Calcium Hydroxylapatite To Treat Gum Recession and Tooth Hypersensitivity
A study testing Calcium hydroxylapatite in people with Gingival Recession, Generalized and Gingival Recession Generalized Moderate, run by American Academy of Facial Esthetics at 1 site in United States.
Trial 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. to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue; 2. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gingival Recession, Generalized, Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate
- What is being tested?
- Calcium hydroxylapatite
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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)
Show all 10Show fewer
- 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.
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
American Academy of Facial Esthetics
South Euclid, Ohio, 44121
About this study
Official title: Evaluating the Use of Calcium Hydroxylapatite With Integral Lidocaine for Improving Gingival Recession and Hypersensitivity
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:
- to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue;
- to determine the efficacy of Radiesse(+) in the reduction of tooth hypersensitivy caused by exposed roots relating to gingival recession;
- to determine the efficacy of Radiesse(+) in the treatment of mild and moderate gingival recession.
Read the detailed description
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.
- Conditions
- Gingival Recession, Generalized, Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Tooth Sensitivity
- Being tested
- Calcium hydroxylapatite
- Keywords
- Gingival recession, Tooth sensitivity, Recessed gums, Gum recession, Attached gingiva, Attached gingiva deficiency
- Medical subject headings
- Gingival Recession, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxylapatiteDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Calcium hydroxylapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Feb 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Academy of Facial Esthetics
- Sponsor type
- Research network
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr. Louis Malcmacher, DMD, Principal investigator, American Academy of Facial Esthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826391
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
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.
PubMed 12787218Nieri 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.
PubMed 23668251Renkema 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.
PubMed 22828081Agudio 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.
PubMed 19722789Kennedy 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.
PubMed 3902907Shalak 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
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.
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.
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.
PubMed 1625148Mythri 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.
PubMed 26941519
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Calcium Hydroxylapatite With Integral Lidocaine for Improving Gingival Recession and Hypersensitivity
- ClinicalTrials.gov ID
- NCT06826391
- Acronym / sponsor ID
- 001
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- American Academy of Facial EstheticsResearch network
- Collaborators
- Merz North America, Inc.
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue;
- to determine the efficacy of Radiesse(+) in the reduction of tooth hypersensitivy caused by exposed roots relating to gingival recession;
- to determine the efficacy of Radiesse(+) in the treatment of mild and moderate gingival recession.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity | Experimental | Device: Calcium hydroxylapatite* 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Patient selection criteria will be limited to male or female patients between the ages of 20-70 years old.
Key exclusion criteria (12 listed)
- • Uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium hydroxylapatiteThis 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. | Device | Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity |
Primary outcome
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
Time frame: 3 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 Gingiva
Time frame: 3 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 12787218Roccuzzo 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.
- Background: PubMed 23668251Nieri 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.
- Background: PubMed 22828081Renkema 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.
- Background: PubMed 19722789Agudio 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.
- Background: PubMed 3902907Kennedy 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.
- BackgroundShalak 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
- BackgroundShalak 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.
- Background5. 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: PubMed 1625148Loe 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.
- Background: PubMed 26941519Mythri 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.
- Causes and treatments for gum recessionLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Louis Malcmacher, DMD principal investigator
American Academy of Facial Esthetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium hydroxylapatite in people with Gingival Recession, Generalized and Gingival Recession Generalized Moderate, run by American Academy of Facial Esthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06826391, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.