Periodontal therapy in diabetic subjects

Not Applicable

Completed

• Conditions: Periodontal disease and diabetes mellitus; Oral Health; Gingivitis and periodontal diseases

• Registration Number: ISRCTN11742127
• Lead Sponsor: King Abdulaziz City for Science and Technology (Saudi Arabia)

Brief Summary

2010 results in: https://doi.org/10.1016/j.ijdm.2010.08.006 (added 04/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-04-01
• Study Start: 2008-06-25
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

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

Exclusion Criteria

1. Use of antibiotics within three months prior to baseline appointment
2. Pregnant or nursing female subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1.1. Probing Pocket Depth (PPD)<br> 1.2. Clinical attachment level (CAL)<br> 1.3. Modified gingival index (MGI)<br> 1.4. Plaque index (PI)<br> 1.5. Bleeding on probing (BOP)<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures