Periodontal therapy in diabetic subjects

Efficacy of mechanical scaling and root planning and adjunctive chemotherapy (doxycycline hyclate 20 mg) on systemic health improvement in diabetics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11742127

Enrollment

500

Registered

2008-06-25

Start date

2006-04-01

Completion date

Unknown

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal disease and diabetes mellitus Oral Health Gingivitis and periodontal diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026