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ISRCTN
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ISRCTN11742127
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ClinicalTrials.gov identifier
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Public title
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Periodontal therapy in diabetic subjects
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Scientific title
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Efficacy of mechanical scaling and root planning and adjunctive chemotherapy (doxycycline hyclate 20 mg) on systemic health improvement in diabetics
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Acronym
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N/A
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Serial number at source
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005
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Study hypothesis
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To evaluate the effectiveness of scaling and root planning (SRP) and adjunctive chemotherapy (doxycycline hyclate 20 mg) on gingival health, specific cytokines and glycaemic control within diabetic subjects.
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Ethics approval
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Research Ethics Committee, Sultan Bin Abdulaziz Humanitarian City, Riyadh, Saudi Arabia
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Study design
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A double-masked, randomised, placebo-controlled, multi-centre trial.
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Countries of recruitment
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Saudi Arabia
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Disease/condition/study domain
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Periodontal disease and diabetes mellitus
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Participants - inclusion criteria
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1. Both males and females, age range 18-65 years old
2. Diabetes, identified as type 1 or 2
3. Have had diabetes for at least 1 year
4. Diabetes is under control by oral hypoglycemic agent or insulin or both
5. Have been on the same type and dose of diabetic medication for the past 6 months
6. Good physical condition with no serious medical conditions or transmittable disease i.e. malignant disease, active hepatitis, free from any cardiac condition that needs antibiotic prophylaxis prior to teeth scaling and root planning
7. Have minimum of 18 remaining natural and non-capped teeth
8. Have minimum of 6 sites in minimum of 2 different quadrants with probing pocket depth (PPD) >=5 mm but <=8 mm
9. Have not had treatment with SRP within 6 months prior to baseline visit
10. Visible supragingival calculus in minimum of 4 teeth in 2 different quadrants
11. Absence of orthodontic bands and brackets and/or dental appliances that would affect scored indices
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Participants - exclusion criteria
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1. Use of antibiotics within three months prior to baseline appointment
2. Pregnant or nursing female subjects
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Anticipated start date
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01/04/2006
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Anticipated end date
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01/04/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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500
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Interventions
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The selected subjects were divided into four groups:
1. One session of SRP at baseline visit only, and placebo tablets 20 mg twice/day starting at baseline visit and continuing for 3 months only
2. One session of SRP at baseline visit only, and doxycycline hyclate (oral, 20 mg twice/day) starting at baseline visit and continuing for 3 months only
3. Two sessions of SRP, first at baseline visit and the second at 6-month visit, and placebo tablets 20 mg twice/day at baseline visit and 6-month visit continuing for 3 months from each visit
4. Two sessions of SRP, first at baseline visit and the second at 6-month visit, and doxycycline hyclate 20 mg twice/day at baseline visit and 6-month visit continuing for 3 months from each visit
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Primary outcome measure(s)
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1. Effectiveness of SRP and adjunctive chemotherapy (doxycycline hyclate 20 mg) on gingival health. The following were assessed at baseline, 3, 6, 9 and 12 months:
1.1. Probing Pocket Depth (PPD)
1.2. Clinical attachment level (CAL)
1.3. Modified gingival index (MGI)
1.4. Plaque index (PI)
1.5. Bleeding on probing (BOP)
2. Effectiveness of SRP and adjunctive chemotherapy (doxycycline hyclate 20 mg) on specific cytokines and glycaemic control in diabetic subjects. Venous blood samples were obtained for laboratory analysis of cytokines (Tumuor Necrosis Factor alpha [TNF-a], Interleukine-1 alpha [IL-1 a]) and to evaluate glycated haemoglobin (HbA1c) for all subjects at baseline, 3, 6, 9 and 12 months.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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King Abdulaziz City for Science and Technology, General Directorate of Research Grants Programmes (Saudi Arabia)
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Trial website
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Publications
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Contact name
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Dr
Sultan
Al Mubarak
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Address
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King Faisal Specialist Hospital and Research Centre
PO Box 64399
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City/town
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Riyadh
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Zip/Postcode
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11536
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Country
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Saudi Arabia
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Tel
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+966 504180209
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Email
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salmubarak@kfshrc.edu.sa
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Sponsor
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King Abdulaziz City for Science and Technology (Saudi Arabia)
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Address
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PO Box 6068
11442
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City/town
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Riyadh
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Zip/Postcode
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11536
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Country
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Saudi Arabia
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Tel
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+966 5620000 Ex 5019
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Email
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aasirvatham@humanitariancity.org.sa
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Sponsor website:
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http://www.kacst.edu.sa/eng/
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Date applied
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12/06/2008
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Last edited
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25/06/2008
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Date ISRCTN assigned
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25/06/2008
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