Gum Disease

About Gum Disease Clinical Trials (Click to Open)

Join Clinical Trials for Gum Disease

General Purpose:

Gum disease (or periodontal disease) is extremely common in the United States, and affects many, many adults. The term gum disease describes a number of conditions that adversely affect the gums and which occur when the bacteria in the mouth accumulate and form plaque.

When plaque hardens, it forms tartar, which if not removed, continues to accumulate and cause increasing damage to the gums and teeth. Gum disease can range in severity from mild gum inflammation (a condition known as gingivitis) to serious gum disease that leads to severe damage to the tissues and bones that support the teeth (periodontitis). In those cases, teeth are often lost as a result.

Fortunately, if identified early, gum disease can be stopped from progressing by controlling the bacterial growth within the mouth. In addition, good oral care practices (such as brushing and flossing) are essential components of effective treatment as well. In addition, various dental procedures that deeply clean plaque from below and above the gum line can help remove bacteria.

Medications may also help in addition to intensive oral treatments, and in the most severe cases, surgery may be required to repair damaged bone and tissue.

Research related to gum disease is focused on developing new and better ways to prevent, diagnose, and treat gingivitis and periodontitis. Additionally, a current topic of interest to many researchers is exploring if any association exists between gum disease and adverse health conditions, and events such as heart disease, diabetes, and certain pregnancy complications.

What Will Gum Disease Clinical Trials Be Like? 

The types of tests and assessments used in gum disease clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures which may be incorporated for use in clinical trials:

  • Detailed exam of the teeth, mouth, and gums.
  • Detailed review of your medical history.
  • Study dentist or doctor may use a metal probe to measure the depth of the narrow grooves between your gums and your teeth.
  • Blood tests to look for indications of an underlying disease or condition.
  • Dental x-rays
  • You may be asked to avoid eating, drinking, chewing gum, smoking, and brushing your teeth for a specific period of time before any study-related evaluations.
  • You may be asked to maintain a log of your diet, as well as behaviors such as smoking, gum chewing, use of mints and mouthwash.
  • You may be asked to complete brief questionnaires to evaluate your quality of life, pain level, and/or level of depression and/or anxiety.
  • Swab of the inner cheeks, teeth, gums and/or tongue to obtain bacteria samples for analysis. 

Typical Gum Disease Clinical Trial Protocol:

Specific examples of clinical trials for gum disease might include the following:

  • A randomized clinical trial in which treatment for periodontitis with a single antibiotic is compared to treatment with a combination of two antibiotics to determine which treatment is a) more effective at repairing damage done by periodontitis, b) which results in fewer side effects, and c) which is subjectively preferred by patients.
  • A randomized clinical trial that investigates the effect of obesity on non-surgical treatment methods for periodontitis. In such a study, patients would be randomly assigned to receive standard treatment with scaling and root planning plus the addition of an antibiotic, or standard treatment plus placebo.
  • A long-term study in which individuals with periodontitis and a diagnosis of coronary heart disease will be followed for two years to observe the occurrence of cardiovascular-related death, heart attack, or stroke. Oral bacterial samples would also be taken from the patients at the start of the study and then later analyzed to see if there was any correlation between the number and types of bacteria present and patient outcomes.
  • A clinical trial in which pregnant women undergo oral examination at 20 weeks gestation to determine the presence of periodontal disease and to submit a blood sample for analysis of various bacterial and inflammatory markers. The women would then be followed until delivery and the researchers would note any adverse pregnancy-related outcomes (such as preterm delivery or high blood pressure). At the time of delivery, women would also undergo another periodontal exam and provide an additional blood sample for comparison to the original samples.

A brief word about randomized trials and placebos: 

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition. 

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of gum and/or tooth disease and any specific diagnoses (i.e., gingivitis)
  • Your history of treatment for gum and/or tooth disease.
  • Your prior and current diagnoses of any health conditions or diseases.
  • Your current medications (including vitamins and other dietary supplements)

Suggested Search Terms: 

 “gum disease prevention,” “gum disease management,” “gum disease treatment,” “gum disease diet,” “gum disease infection,” “gum disease diabetes,” “gum disease heart disease,” “gum disease pregnancy,” and “pediatric gum disease.” 

Current Search Term:

“Gum Disease”

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Risk Perception of Periodontal Disease

Condition:   Periodontal Diseases
Intervention:   Behavioral: Exposure
Sponsor:   University of Benin

Influence of Smoking on Periodontal Healing One Year After Active Treatment

Conditions:   Periodontal Diseases;   Smoking
Intervention:   Procedure: Healing after treatment
Sponsor:   Dalarna County Council, Sweden

Effects of Periodontal Treatment on HIV-infected Patients

Conditions:   HIV/AIDS;   Periodontal Diseases
Intervention:   Procedure: Basic periodontal treatment
Sponsor:   University of Sao Paulo

Periodontal Treatment and Psychology

Condition:   Gum Disease
Intervention:   Other: Psychological measurements
Sponsor:   Ozge Gokturk

Role of IL-37 Genetic Variants in Modulating Innate Immune Response to Periodontal Pathogens

Condition:   Periodontal Diseases
Sponsors:   University of North Carolina, Chapel Hill;   National Institute of Dental and Craniofacial Research (NIDCR)

Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration for Periodontal Intrabony Defects and Grade II Furcation Defects.

Condition:   Periodontal Diseases
Intervention:   Procedure: Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.
Sponsor:   Indiana University

A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period

Condition:   Gingival Diseases
Interventions:   Other: Fluoride Toothpaste 1;   Other: Fluoride Toothpaste 2
Sponsor:   Unilever R&D
Active, not recruiting

Evaluation and Comparison of Efficacy of PeriActive Mouthwash to Chlorhexidine 0.12% Mouth Rinse

Condition:   Periodontal Diseases
Intervention:   Other: PeriActive
Sponsors:   Izun Pharma Ltd;   Jerusalem Perio Center;   Herzog Hospital
Not yet recruiting

Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects

Conditions:   Periodontal Diseases;   Bone Resorption
Interventions:   Drug: Platelet rich fibrin;   Drug: Bioactive Glass
Sponsors:   Dr. D. Y. Patil Dental College & Hospital;   Santosh University

Global Behavior and Periodontal Disease in Down's Syndrome Patients

Conditions:   Behavior;   Periodontal Diseases
Intervention:   Behavioral: Behavior Analysis
Sponsors:   University of Sao Paulo;   Fundação de Amparo à Pesquisa do Estado de São Paulo

Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis

Condition:   Periodontal Disease
Interventions:   Biological: ST266;   Drug: Saline (0.9% NaCl)
Sponsor:   Noveome Biotherapeutics, formerly Stemnion
Active, not recruiting

Dental Engagement Study Behavior Modification

Intervention:   Genetic: IL-1 genetic test for risk of severe periodontitis
Sponsors:   Interleukin Genetics, Inc.;   Duke University;   Kaiser Permanente

EMD and/or Bone Substitute for the Treatment of Class II Furcations

Condition:   Periodontal Disease
Interventions:   Drug: EMD;   Device: βTCP/HA;   Procedure: Flap access surgery
Sponsor:   University of Campinas, Brazil

Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease

Conditions:   Periodontal Disease;   Vitamin D Deficiency
Interventions:   Drug: Cholecalciferol;   Drug: Placebo
Sponsor:   Augusta University
Unknown status

Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi

Conditions:   Preterm Birth;   Periodontal Disease;   Caries, Dental
Intervention:   Dietary Supplement: Xylitol gum
Sponsor:   Baylor College of Medicine

Observational Study of the Association Between Periodontal Disease and Cardiovascular Disease

Conditions:   Periodontal Disease;   Coronary Artery Disease
Sponsor:   Texas Tech University Health Sciences Center

Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine

Condition:   Periodontal Disease
Sponsor:   Tatyasaheb Kore Dental College

Kidney and Periodontal Disease Study

Conditions:   Chronic Kidney Disease;   Periodontal Disease
Interventions:   Procedure: Scaling and root planing;   Drug: Minocycline
Sponsor:   University of California, San Francisco
Active, not recruiting

Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population

Conditions:   Periodontal Disease;   Type 2 Diabetes Mellitus
Interventions:   Drug: Placebo;   Drug: Doxycycline
Sponsors:   Medical University of South Carolina;   National Center for Research Resources (NCRR)

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

Conditions:   Immunosuppression;   Periodontal Disease;   Healthy Subjects;   Healthy Volunteer
Sponsor:   National Institute of Dental and Craniofacial Research (NIDCR)

Dental Plaque Removal Study

Conditions:   Gingivitis;   Gum Disease
Interventions:   Device: Manual Toothbrush only;   Device: MTB + Waterpik Ultra Water Flosser 'High';   Device: MTB + Floss (MTB+Floss)
Sponsors:   University of North Carolina, Chapel Hill;   Philips Oral Healthcare

Periodontal Disease and Preterm Birth

Conditions:   Periodontal Disease;   Preterm Birth;   Low Birth Weight
Sponsor:   University of Oklahoma

Apoptic Biomarkers of Periodontal Disease

Condition:   Periodontitis
Intervention:   Other: collection of gingival crevicular fluid
Sponsor:   University of Michigan

Prevention of Pre-Term Birth by Treatment of Periodontal Disease

Conditions:   Periodontal Diseases;   Premature Birth;   Pre-Eclampsia
Intervention:   Procedure: Treatment of periodontal disease
Sponsors:   King Edward Memorial Hospital;   The University of Western Australia
Unknown status

Impact of Gum Infection on Heart Disease

Conditions:   Cardiovascular Disease;   Periodontal Disease
Interventions:   Procedure: Early Periodontal Treatment;   Procedure: Usual Dental Hygiene
Sponsors:   Boston University;   National Institute of Dental and Craniofacial Research (NIDCR)

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