Evaluating the Use of Calcium Hydroxylapatite with Integral Lidocaine for Improving Gingival Recession and Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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
研究组 & 干预措施
Evaluating the Use of Calcium Hydroxylapatite For Improving Gingival Recession and Hypersensitivity
- 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.
干预措施: Calcium hydroxylapatite (Device)
结局指标
主要结局
Change from Baseline Of Gingival Recession With Calcium Hydroxylapatite Injections In Attached Gingiva
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点