Gingival ScalingPhase 1NCT01255254
The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes
A Phase 1 study testing Gingival scaling in people with Gingival Scaling and Metabolic Control, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Gingival Scaling, Metabolic Control
- What is being tested?
- Gingival scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 1
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25- 75 years;
- Type 2 diabetes;
- Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm ("established periodontitis")16
Who cannot join
- Periodontal treatment within the last 3 months
- The use of antibiotics within the last 4 weeks
- Pregnancy or the intention to be pregnant in the next 4 months
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Periodontology, School of Graduate Dentistry Rambam Health care campus
Haifa
Dr. Rina Elmaleh, DMD, +97206470740, r_elmaleh@rambam.health.gov.il
Prof Eli Machtei, DMD
About this study
The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.
- Conditions
- Gingival Scaling, Metabolic Control
- Being tested
- Gingival scaling
- Keywords
- he effect of gingival scaling on Metabolic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival scalingProcedure or surgery
Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.
| Study group | Role | What they receive |
|---|---|---|
| A: Scaling group | Experimental | The experimental group will receive oral hygiene instruction (OHI) and full-mouth scaling using standard rigid Gracey curettes (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA) and ultrasonic instrumentation (EMS piezoelectric system, Electro Medical Systems, Nyon, Switzerland) at week 1-2 and at a second reinforcement visit at 6-8 weeks. Subjects will also be instructed to rinse with 10ml of Chlorhexidine 0.2% mouthrinse twice daily for 30 seconds for the duration of the study. Receives: Procedure: Gingival scaling |
| B: Control group | No intervention | The control group will receive no periodontal treatment during the study. After completion of the study, these patients will be given oral hygiene instruction and a full mouth scaling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control
Blood sample that measures fasting plasma glucose and the HbA1c level.
Measured: 3 months
Secondary outcomes (1)
Inflammation
Blood sample to measure C reactive protein (inflammatory marker).
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 posted7 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival ScalingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255254
- Sponsor's protocol ID
- RMB 0350-10 CTIL
- Status last verified
- Aug 2010
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT01255254
- Acronym / sponsor ID
- RMB 0350-10 CTIL
- Conditions
- Gingival Scaling, Metabolic Control
- Keywords
- he effect of gingival scaling on Metabolic control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 7 Dec 2010 (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.
The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Scaling group | Experimental | Procedure: Gingival scalingThe experimental group will receive oral hygiene instruction (OHI) and full-mouth scaling using standard rigid Gracey curettes (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA) and ultrasonic instrumentation (EMS piezoelectric system, Electro Medical Systems, Nyon, Switzerland) at week 1-2 and at a second reinforcement visit at 6-8 weeks. Subjects will also be instructed to rinse with 10ml of Chlorhexidine 0.2% mouthrinse twice daily for 30 seconds for the duration of the study. |
| B: Control group | No intervention | –The control group will receive no periodontal treatment during the study. After completion of the study, these patients will be given oral hygiene instruction and a full mouth scaling. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 25- 75 years;
- Type 2 diabetes;
- Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm ("established periodontitis")16
Key exclusion criteria (3 listed)
- Periodontal treatment within the last 3 months
- The use of antibiotics within the last 4 weeks
- Pregnancy or the intention to be pregnant in the next 4 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 |
|---|---|---|
| Gingival scalingOral hygeine instruction and gingival scaling using hand and ultrsonic instruments. | Procedure or surgery | A: Scaling group |
Primary outcome
Metabolic control
Time frame: 3 months
Blood sample that measures fasting plasma glucose and the HbA1c level.
1 secondary outcome
Inflammation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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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.
Department of Periodontology, School of Graduate Dentistry Rambam Health care campus
Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gingival scaling in people with Gingival Scaling and Metabolic Control, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Dec 2010. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2010.