GingivitisNCT03445286
Silver Diamine Fluoride and Gingivitis in Geriatric Patients
A study testing Silver Diamine Fluoride and Normal Saline in people with Gingivitis, run by Texas A & M University Baylor College Of Dentistry at 2 sites in United States.
Trial summary
Gingivitis in the geriatric population is one of the growing global public health concerns, thus finding the most effective and non-invasive approach to prevent and treat gingivitis in the geriatric population is essential to prevent tooth loss and maintain oral health and function. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Silver Diamine Fluoride and Normal Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2019to 22 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age group 65 years and older
- Males and females
- Minimum of 6 remaining teeth with gingivitis (at least one posterior tooth should be present)
- Every participant should agree to not brush or floss three days prior the data collection
- Every participant should agree to not use any mouthwash or Fluoride treatment for the entire study period
- All socioeconomic status included
Who cannot join
- Active chemotherapy or radiotherapy
- Known history of allergy to Silver Particles
- Uncontrolled diabetes
- Use of antibiotics in the last three months
- Periodontal therapy in the last 3 months
- Mouth rinse such as Chlorhexidine (CHX) at least 30 days prior to the study
Show all 10Show fewer
- Smoking
- Epileptic patients on medication cause gingival overgrowth
- Patients who are unable to give consent
- Teeth with periodontitis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Notre Dame Court (Seniors Independent Living)
Dallas, Texas, 75208
Dickinson Place (Seniors Independent Living)
Dallas, Texas, 75246
About this study
Official title: Effect of Silver Diamine Fluoride on the Treatment of Gingivitis in Geriatric Patients
Gingivitis in the geriatric population is one of the growing global public health concerns, thus finding the most effective and non-invasive approach to prevent and treat gingivitis in the geriatric population is essential to prevent tooth loss and maintain oral health and function. Silver Diamine Fluoride (SDF) is Class II medical device. It was cleared for use in US August 2014 and became commercially available in April 2015. It is a chemical agent which has bifunctional properties. The silver itself kills caries causing bacteria directly. Silver and fluoride together interact to form fluorapatite, in addition, assist in hardening the teeth and preventing further demineralization.
Even though SDF has been approved in dental caries prevention and treatment, there are no published studies or evidence that evaluated the direct effect of SDF on gingivitis. If SDF improves or prevents gingivitis is unknown. The main goal of this clinical study is to investigate the effect of SDF on gingival status in geriatric patients with gingivitis. There is an urgent need to solve this common oral disease in the geriatric population. The logic for this research in a geriatric population is to find the most effective approach to treat gingivitis to prevent tooth loss and maintain oral health and function.
To find an effective approach to treat gingivitis in the geriatric group, we will investigate the effectiveness of SDF application on gingival tissues in this group. The patients with gingivitis will be randomly allocated to two groups: group1(case group) will receive SDF application and group 2 (control group) will receive a normal saline application. The gingiva will be evaluated for both groups at baseline before the application. Then 2 weeks and 4 weeks after the last application of the intervention. In addition, a sample of plaque will be taken from the teeth selected in this study by swab using the dental kit (Ubiome) before and after both applications to quantify the presence of bacterial pathogen at baseline and follow up visits. The feasibility of this proposed therapy is supported by published literature that has shown that SDF was effective in dental and root caries prevention and treatment in geriatric patients.
Read the detailed description
The Aims
- Aim 1 To investigate the effect of SDF application on gingival status in elder patients with gingivitis. To accomplish this aim, the subjects with gingivitis will be randomly allocated to two groups: group 1(case group) will receive SDF application and group 2 (control group) will receive Normal Saline. The SDF and normal saline will apply on the selected teeth with gingivitis once a week during a three-week period. The gingival status will be evaluated at baseline before the application of either SDF or normal saline. Then at the second week and fourth week after the final application. The measurable outcomes will be Plaque Index (PI) and the Gingival Index (GI). In addition, record of existing brushing and flossing habits. If SDF application shows an improvement in the gingival condition (reduction in the plaque and gingival indices) in treatment group comparing to the control group it indicates that its effectiveness not only on dental caries as published, but it is also may extended to include gingivitis.
- Aim 2 To quantify the presence of bacterial pathogen in the dental biofilm. To accomplish this aim, a sample of dental plaque will be taken from the teeth selected in this study by swab using the dental kit (Ubiome) before and after the SDF or normal saline application to quantify the presence of bacterial pathogen at baseline before the application, 2 weeks and 4 weeks after the application.
Summary:
The proposed therapeutic intervention of Silver Diamine Fluoride (SDF) in treating geriatric patients with gingivitis will establish a new adjunctive and inexpensive protocol for treatment of gingivitis. Gingivitis is inflammation of gingival tissues caused by dental biofilm bacterial infection. Left untreated, gingivitis will cause tooth loss. The preliminary results will provide new recommendations for treating geriatric patients in a safe, effective, and low-cost manner. This study will also address the gap in scientific knowledge regarding the use of SDF to treat gingivitis in elderly patients.
Research Hypothesis: The application of SDF varnish is expected to improve the gingival condition and can be an effective approach in the treatment of gingivitis in geriatric patients.
Null Hypothesis: The application of SDF varnish does not improve the gingival condition and cannot be an effective approach in the treatment of gingivitis in geriatric patients.
Research Question: Does the application of silver Diamine Fluoride on teeth with gingivitis will improve the gingival condition in geriatric patients with gingivitis
- Conditions
- Gingivitis
- Being tested
- Silver Diamine Fluoride, Normal Saline
- Keywords
- Gingivitis and geriatric patients, Silver Diamine Fluoride and gingivitis, Sliver Diamine Fluoride
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDevice
Also called Advantage Arrest
Silver Diamine Fluoride (Advantage Arrest) for the experimental group
Normal SalineOther
Normal Saline for the control group
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluordie Application | Experimental | This group will receive Silver Diamine Fluoride (SDF) application once every week within three weeks period Receives: Device: Silver Diamine Fluoride |
| Normal Saline | Placebo comparator | This control group will receive normal saline application once a week within a a three-week period Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Gingival Index GI (for Gingival Inflammation)
The change in Gingival Index GI (for Gingival Inflammation) from Baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
Measured: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
The change in Plaque Index PI (for dental plaque accumulation)
The change in Plaque Index PI (for dental plaque accumulation) from baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
Measured: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
Secondary outcomes (1)
Assessment of microbial counts in Dental Plaque
Dental Plaque sample taken from each participant, labeled and send to the lab for analysis of bacterial counts (using Ubiome dental kit)
Measured: Three times evaluation at baseline before the application of the intervention, then at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start29 Jan 2019
- Primary completion10 Jan 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants with gingivitis are randomly allocated to two groups: group 1(case group) who will receive SDF application once every week within three weeks period and group 2 (control group) who will receive normal saline application once a week within three-week period
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A & M University Baylor College Of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Noureldin, Texas A & M University Baylor College Of Dentistry
- Investigators
- WEDAD ALSHEHRI, BSDH, MS., Study director, Texas A&M University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445286
- Sponsor's protocol ID
- IRB2017-0917
- Status last verified
- Oct 2020
- First submitted
- 13 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Noureldin A, Alshehri W, Tapias H, Mallonee L, Mancl LM, Milgrom P, Svboda K. Efficacy of 38% silver diamine fluoride in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes: A randomized controlled pilot trial. J Dent. 2024 Apr;143:104890. doi: 10.1016/j.jdent.2024.104890. Epub 2024 Feb 20.
PubMed 38387597
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silver Diamine Fluoride on the Treatment of Gingivitis in Geriatric Patients
- ClinicalTrials.gov ID
- NCT03445286
- Acronym / sponsor ID
- IRB2017-0917
- Conditions
- Gingivitis
- Keywords
- Gingivitis and geriatric patients, Silver Diamine Fluoride and gingivitis, Sliver Diamine Fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Texas A & M University Baylor College Of DentistryUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 26 Feb 2018 (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.
Gingivitis in the geriatric population is one of the growing global public health concerns, thus finding the most effective and non-invasive approach to prevent and treat gingivitis in the geriatric population is essential to prevent tooth loss and maintain oral health and function. Silver Diamine Fluoride (SDF) is Class II medical device. It was cleared for use in US August 2014 and became commercially available in April 2015. It is a chemical agent which has bifunctional properties. The silver itself kills caries causing bacteria directly. Silver and fluoride together interact to form fluorapatite, in addition, assist in hardening the teeth and preventing further demineralization.
Even though SDF has been approved in dental caries prevention and treatment, there are no published studies or evidence that evaluated the direct effect of SDF on gingivitis. If SDF improves or prevents gingivitis is unknown. The main goal of this clinical study is to investigate the effect of SDF on gingival status in geriatric patients with gingivitis. There is an urgent need to solve this common oral disease in the geriatric population. The logic for this research in a geriatric population is to find the most effective approach to treat gingivitis to prevent tooth loss and maintain oral health and function.
To find an effective approach to treat gingivitis in the geriatric group, we will investigate the effectiveness of SDF application on gingival tissues in this group. The patients with gingivitis will be randomly allocated to two groups: group1(case group) will receive SDF application and group 2 (control group) will receive a normal saline application. The gingiva will be evaluated for both groups at baseline before the application. Then 2 weeks and 4 weeks after the last application of the intervention. In addition, a sample of plaque will be taken from the teeth selected in this study by swab using the dental kit (Ubiome) before and after both applications to quantify the presence of bacterial pathogen at baseline and follow up visits. The feasibility of this proposed therapy is supported by published literature that has shown that SDF was effective in dental and root caries prevention and treatment in geriatric patients.
Detailed description
The Aims
- Aim 1 To investigate the effect of SDF application on gingival status in elder patients with gingivitis. To accomplish this aim, the subjects with gingivitis will be randomly allocated to two groups: group 1(case group) will receive SDF application and group 2 (control group) will receive Normal Saline. The SDF and normal saline will apply on the selected teeth with gingivitis once a week during a three-week period. The gingival status will be evaluated at baseline before the application of either SDF or normal saline. Then at the second week and fourth week after the final application. The measurable outcomes will be Plaque Index (PI) and the Gingival Index (GI). In addition, record of existing brushing and flossing habits. If SDF application shows an improvement in the gingival condition (reduction in the plaque and gingival indices) in treatment group comparing to the control group it indicates that its effectiveness not only on dental caries as published, but it is also may extended to include gingivitis.
- Aim 2 To quantify the presence of bacterial pathogen in the dental biofilm. To accomplish this aim, a sample of dental plaque will be taken from the teeth selected in this study by swab using the dental kit (Ubiome) before and after the SDF or normal saline application to quantify the presence of bacterial pathogen at baseline before the application, 2 weeks and 4 weeks after the application.
Summary:
The proposed therapeutic intervention of Silver Diamine Fluoride (SDF) in treating geriatric patients with gingivitis will establish a new adjunctive and inexpensive protocol for treatment of gingivitis. Gingivitis is inflammation of gingival tissues caused by dental biofilm bacterial infection. Left untreated, gingivitis will cause tooth loss. The preliminary results will provide new recommendations for treating geriatric patients in a safe, effective, and low-cost manner. This study will also address the gap in scientific knowledge regarding the use of SDF to treat gingivitis in elderly patients.
Research Hypothesis: The application of SDF varnish is expected to improve the gingival condition and can be an effective approach in the treatment of gingivitis in geriatric patients.
Null Hypothesis: The application of SDF varnish does not improve the gingival condition and cannot be an effective approach in the treatment of gingivitis in geriatric patients.
Research Question: Does the application of silver Diamine Fluoride on teeth with gingivitis will improve the gingival condition in geriatric patients with gingivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants with gingivitis are randomly allocated to two groups: group 1(case group) who will receive SDF application once every week within three weeks period and group 2 (control group) who will receive normal saline application once a week within three-week period
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluordie Application | Experimental | Device: Silver Diamine FluorideThis group will receive Silver Diamine Fluoride (SDF) application once every week within three weeks period |
| Normal Saline | Placebo comparator | Other: Normal SalineThis control group will receive normal saline application once a week within a a three-week period |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age group 65 years and older
- Males and females
- Minimum of 6 remaining teeth with gingivitis (at least one posterior tooth should be present)
- Every participant should agree to not brush or floss three days prior the data collection
- Every participant should agree to not use any mouthwash or Fluoride treatment for the entire study period
Key exclusion criteria (10 listed)
- Active chemotherapy or radiotherapy
- Known history of allergy to Silver Particles
- Uncontrolled diabetes
- Use of antibiotics in the last three months
- Periodontal therapy in the last 3 months
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 |
|---|---|---|
| Silver Diamine FluorideAlso: Advantage ArrestSilver Diamine Fluoride (Advantage Arrest) for the experimental group | Device | Silver Diamine Fluordie Application |
| Normal SalineNormal Saline for the control group | Other | Normal Saline |
Primary outcome
The change in Gingival Index GI (for Gingival Inflammation)
Time frame: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
The change in Gingival Index GI (for Gingival Inflammation) from Baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
The change in Plaque Index PI (for dental plaque accumulation)
Time frame: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
The change in Plaque Index PI (for dental plaque accumulation) from baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
1 secondary outcome
Assessment of microbial counts in Dental Plaque
Time frame: Three times evaluation at baseline before the application of the intervention, then at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 38387597Noureldin A, Alshehri W, Tapias H, Mallonee L, Mancl LM, Milgrom P, Svboda K. Efficacy of 38% silver diamine fluoride in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes: A randomized controlled pilot trial. J Dent. 2024 Apr;143:104890. doi: 10.1016/j.jdent.2024.104890. Epub 2024 Feb 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
WEDAD ALSHEHRI, BSDH, MS. study director
Texas A&M University College of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride and Normal Saline in people with Gingivitis, run by Texas A & M University Baylor College Of Dentistry at 2 sites 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in Gingival Index GI (for Gingival Inflammation) (time frame: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine). 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 NCT03445286, which also lists 1 linked publication.
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 8 Oct 2020.