XerostomiaNCT00048685
Study of Oral Bacteria in Patients With Dry Mouth
An observational study of Xerostomia and Autoimmune Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will examine the types of bacteria present in the dental plaque of patients with persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining the normal mineralization of teeth. People who suffer from dry mouth usually have a significant increase in tooth decay (caries). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Xerostomia, Autoimmune Diseases
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2004
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Salivary Flow = 0.1ml/min pooled unstimulated; and
- A diagnosis of SS (primary or secondary)
- A diagnosis of non-SS auto-immune disease
- The use of a medication with known xerostomic effect
- Subjective xerostomia or xerophthalmia
- The presence of permanent teeth.
Who cannot join
- Child and Adolescent:
- Children and Adolescents will not be included in the study due to the presence of deciduous teeth which are less suitable for bonding and which show an altered enamel morphology and pattern of plaque accumulation
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Incidence and Frequency of Cariogenic Microflora in Patients With Clinical Xerostomia and Autoimmune Disease
This study will examine the types of bacteria present in the dental plaque of patients with persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining the normal mineralization of teeth. People who suffer from dry mouth usually have a significant increase in tooth decay (caries). This study will determine if this increase is due solely to reduced salivary flow or also to an increase in certain types of bacteria in the mouth.
Patients participating in the following NIDCR protocols may be eligible for this study: Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary Evaluation in Normal Volunteers (94-D-0018).
Read more
Participants will have three appointments at the NIH dental clinic as follows:
Visit 1
Dental examination and instruction on keeping a detailed diary of food intake.
Visit 2 (1 week after visit 1)
Attachment of a bacteria collection device (described below) to the side of a tooth.
Visit 3 (48 hours after visit 2)
Removal of the collection device, tooth cleaning and polishing, and submission of food diary.
The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from slicing an extracted healthy tooth donated by another patient. The donated teeth are either extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth. The dental cement used for bonding can be removed after 48 hours with no damage to the surface of the participant's tooth.
Read the detailed description
Although significant improvements have been made in the dental health status of the US population, dental caries remains a significant problem. The most recent Surgeon General's Report (2000) noted that 20% of the US population bears 60% of the caries burden. Caries incidence is even higher in children of minorities, the chronically ill, the physically handicapped, the elderly and the institutionalized.
Dental Caries is a multi-factorial disease in which the fermentation of dietary carbohydrate by oral bacteria results in acid dissolution of tooth structure. Important risk factors include the frequency of dietary carbohydrate intake, intra-oral plaque levels, the levels of cariogenic oral bacteria, salivary insufficiency and past fluoride exposure.
A medical condition shown to be associated with increased caries risk and caries incidence is Sjogren's syndrome (Kolavic et al 1997, Pedersen et al 1999, Almstahl et al 1999). Sjogren's syndrome (SS) predominantly affects women and is an auto-immune disorder characterized by an epitheliitis or exocrinopathy. Both primary and secondary forms are described. Secondary SS sees the condition co-exist with other auto-immune disease such as rheumatoid arthritis (See reviews by Fox and Maruyama 1997, Fox et al 1999, Pflugfelder 1998 )
A recent study by Sreebny and Zhu (Adv. Dent Res 1996), demonstrated that individuals with a diagnosis of SS are nearly 40% more likely to harbor high levels of the species Lactobacillus in plaque and saliva than healthy individuals. LB has been shown in to be a major etiological agent in dental caries progression.
The principal hypothesis of this study is that SS patients are at a higher risk of caries development not just because of reduced salivary flow (xerostomia) but also changes in the output of organic and inorganic microbial regulatory components in saliva secondary to their auto-immune disease. These alterations favor a selective increase in the proportion of cariogenic microflora in plaque located on their teeth. Specifically, mutans streptococci (MS) and Lactobacillus (LB) species are increased in frequency and number in SS patients compared with xerostomic patients with no detectable auto-immune disease.
The proposed study will investigate microbial counts of MS and LB in the plaque of patients with a clinical diagnosis of markedly reduced salivary flow (pooled unstimulated flow \&eq; 0.1 ml/min). All clinical procedures will take place at NIH. Some samples and all data, without any patient identifiers, will be analyzed outside.
Plaque samples will be collected from sites identified to be at high-risk for caries initiation and development. It is generally accepted that discernment of microbial etiology is blunted by using salivary or pooled plaque monitoring of MS and LB as a surrogate for samples of plaque in areas of high caries risk. This is supported by current knowledge of the biology of MS/LB and expected locations of carious lesions.
Saliva samples will not be collected due to difficulties in obtaining sufficient fluid as a result of the concurrent xerostomia.
The proposed study will examine the relationship between MS/LB and reduced salivary flow in two patient groups:
- A patient group with reduced salivary flow AND a diagnosis of primary or secondary SS (as per the Revised International Criteria for diagnosis of SS) OR auto-immune disease of non-SS etiology.
- A non-disease control group, who do not meet the criteria for SS, with reduced salivary flow AND who have suffered subjective symptoms of xerostomia or xerophthalmia for a period longer than 6 months OR who are taking medication with xerogenic effect.
Plaque micro-organisms will be harvested from a "collection device" bonded to the surface of a posterior tooth shown to be at high risk for caries development. Plaque collected in this way has been shown to closely simulate the complex ecology of a mature cariogenic plaque. The harvested organisms will then be plated on non-selective media for enumeration of total microbial load and on selective media for enumeration of specific cariogenic bacteria.
More comprehensive knowledge of the effect of SS on microbial flora in different predeliction sites for oral diseases would be of great value for effective treatment planning in SS and for the evaluation of the effect of oral treatments and of preventive measures implemented in individuals with SS.
- Conditions
- Xerostomia, Autoimmune Diseases
- Keywords
- Caries, Bacteria, Saliva, Teeth, Autoimmune, Dry Mouth, Salivary Gland Dysfunction, Sjogren's Syndrome
- Medical subject headings
- Xerostomia, Autoimmune Diseases, Sjogren's Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2002 (estimated)
- Study startNov 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies 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
- Observational
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048685
- Sponsor's protocol ID
- 030026
- Other IDs
- 03-D-0026
- Status last verified
- Aug 2004
- First submitted
- 5 Nov 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Almstahl A, Kroneld U, Tarkowski A, Wikstrom M. Oral microbial flora in Sjogren's syndrome. J Rheumatol. 1999 Jan;26(1):110-4.
PubMed 9918250Babaahmady KG, Challacombe SJ, Marsh PD, Newman HN. Ecological study of Streptococcus mutans, Streptococcus sobrinus and Lactobacillus spp. at sub-sites from approximal dental plaque from children. Caries Res. 1998;32(1):51-8. doi: 10.1159/000016430.
PubMed 9438572Boutsi EA, Paikos S, Dafni UG, Moutsopoulos HM, Skopouli FN. Dental and periodontal status of Sjogren's syndrome. J Clin Periodontol. 2000 Apr;27(4):231-5. doi: 10.1034/j.1600-051x.2000.027004231.x.
PubMed 10783835
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Frequency of Cariogenic Microflora in Patients With Clinical Xerostomia and Autoimmune Disease
- ClinicalTrials.gov ID
- NCT00048685
- Acronym / sponsor ID
- 030026
- Conditions
- Xerostomia, Autoimmune Diseases
- Keywords
- Caries, Bacteria, Saliva, Teeth, Autoimmune, Dry Mouth, Salivary Gland Dysfunction, Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Nov 2002
- Study completion
- Aug 2004
- First posted
- 6 Nov 2002 (estimated)
- 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.
This study will examine the types of bacteria present in the dental plaque of patients with persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining the normal mineralization of teeth. People who suffer from dry mouth usually have a significant increase in tooth decay (caries). This study will determine if this increase is due solely to reduced salivary flow or also to an increase in certain types of bacteria in the mouth.
Patients participating in the following NIDCR protocols may be eligible for this study: Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary Evaluation in Normal Volunteers (94-D-0018).
Participants will have three appointments at the NIH dental clinic as follows:
Visit 1
Dental examination and instruction on keeping a detailed diary of food intake.
Visit 2 (1 week after visit 1)
Attachment of a bacteria collection device (described below) to the side of a tooth.
Visit 3 (48 hours after visit 2)
Removal of the collection device, tooth cleaning and polishing, and submission of food diary.
The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from slicing an extracted healthy tooth donated by another patient. The donated teeth are either extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth. The dental cement used for bonding can be removed after 48 hours with no damage to the surface of the participant's tooth.
Detailed description
Although significant improvements have been made in the dental health status of the US population, dental caries remains a significant problem. The most recent Surgeon General's Report (2000) noted that 20% of the US population bears 60% of the caries burden. Caries incidence is even higher in children of minorities, the chronically ill, the physically handicapped, the elderly and the institutionalized.
Dental Caries is a multi-factorial disease in which the fermentation of dietary carbohydrate by oral bacteria results in acid dissolution of tooth structure. Important risk factors include the frequency of dietary carbohydrate intake, intra-oral plaque levels, the levels of cariogenic oral bacteria, salivary insufficiency and past fluoride exposure.
A medical condition shown to be associated with increased caries risk and caries incidence is Sjogren's syndrome (Kolavic et al 1997, Pedersen et al 1999, Almstahl et al 1999). Sjogren's syndrome (SS) predominantly affects women and is an auto-immune disorder characterized by an epitheliitis or exocrinopathy. Both primary and secondary forms are described. Secondary SS sees the condition co-exist with other auto-immune disease such as rheumatoid arthritis (See reviews by Fox and Maruyama 1997, Fox et al 1999, Pflugfelder 1998 )
A recent study by Sreebny and Zhu (Adv. Dent Res 1996), demonstrated that individuals with a diagnosis of SS are nearly 40% more likely to harbor high levels of the species Lactobacillus in plaque and saliva than healthy individuals. LB has been shown in to be a major etiological agent in dental caries progression.
The principal hypothesis of this study is that SS patients are at a higher risk of caries development not just because of reduced salivary flow (xerostomia) but also changes in the output of organic and inorganic microbial regulatory components in saliva secondary to their auto-immune disease. These alterations favor a selective increase in the proportion of cariogenic microflora in plaque located on their teeth. Specifically, mutans streptococci (MS) and Lactobacillus (LB) species are increased in frequency and number in SS patients compared with xerostomic patients with no detectable auto-immune disease.
The proposed study will investigate microbial counts of MS and LB in the plaque of patients with a clinical diagnosis of markedly reduced salivary flow (pooled unstimulated flow \&eq; 0.1 ml/min). All clinical procedures will take place at NIH. Some samples and all data, without any patient identifiers, will be analyzed outside.
Plaque samples will be collected from sites identified to be at high-risk for caries initiation and development. It is generally accepted that discernment of microbial etiology is blunted by using salivary or pooled plaque monitoring of MS and LB as a surrogate for samples of plaque in areas of high caries risk. This is supported by current knowledge of the biology of MS/LB and expected locations of carious lesions.
Saliva samples will not be collected due to difficulties in obtaining sufficient fluid as a result of the concurrent xerostomia.
The proposed study will examine the relationship between MS/LB and reduced salivary flow in two patient groups:
- A patient group with reduced salivary flow AND a diagnosis of primary or secondary SS (as per the Revised International Criteria for diagnosis of SS) OR auto-immune disease of non-SS etiology.
- A non-disease control group, who do not meet the criteria for SS, with reduced salivary flow AND who have suffered subjective symptoms of xerostomia or xerophthalmia for a period longer than 6 months OR who are taking medication with xerogenic effect.
Plaque micro-organisms will be harvested from a "collection device" bonded to the surface of a posterior tooth shown to be at high risk for caries development. Plaque collected in this way has been shown to closely simulate the complex ecology of a mature cariogenic plaque. The harvested organisms will then be plated on non-selective media for enumeration of total microbial load and on selective media for enumeration of specific cariogenic bacteria.
More comprehensive knowledge of the effect of SS on microbial flora in different predeliction sites for oral diseases would be of great value for effective treatment planning in SS and for the evaluation of the effect of oral treatments and of preventive measures implemented in individuals with SS.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Salivary Flow = 0.1ml/min pooled unstimulated; and
- A diagnosis of SS (primary or secondary)
- A diagnosis of non-SS auto-immune disease
- The use of a medication with known xerostomic effect
- Subjective xerostomia or xerophthalmia
Key exclusion criteria (2 listed)
- Child and Adolescent:
- Children and Adolescents will not be included in the study due to the presence of deciduous teeth which are less suitable for bonding and which show an altered enamel morphology and pattern of plaque accumulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 9918250Almstahl A, Kroneld U, Tarkowski A, Wikstrom M. Oral microbial flora in Sjogren's syndrome. J Rheumatol. 1999 Jan;26(1):110-4.
- Background: PubMed 9438572Babaahmady KG, Challacombe SJ, Marsh PD, Newman HN. Ecological study of Streptococcus mutans, Streptococcus sobrinus and Lactobacillus spp. at sub-sites from approximal dental plaque from children. Caries Res. 1998;32(1):51-8. doi: 10.1159/000016430.
- Background: PubMed 10783835Boutsi EA, Paikos S, Dafni UG, Moutsopoulos HM, Skopouli FN. Dental and periodontal status of Sjogren's syndrome. J Clin Periodontol. 2000 Apr;27(4):231-5. doi: 10.1034/j.1600-051x.2000.027004231.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia and Autoimmune Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) 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 6 inclusion and 2 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 4 Mar 2008. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00048685, which also lists 3 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 4 Mar 2008.