Periodontal therapy in diabetic subjects

ISRCTN	ISRCTN11742127
DOI	https://doi.org/10.1186/ISRCTN11742127
Protocol serial number	005
Sponsor	King Abdulaziz City for Science and Technology (Saudi Arabia)
Funder	King Abdulaziz City for Science and Technology, General Directorate of Research Grants Programmes (Saudi Arabia)

Submission date: 12/06/2008
Registration date: 25/06/2008
Last edited: 04/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sultan Al Mubarak
Scientific

King Faisal Specialist Hospital and Research Centre
PO Box 64399
Riyadh
11536
Saudi Arabia

Phone	+966 504180209
Email	salmubarak@kfshrc.edu.sa

Study information

Primary study design	Interventional
Study design	A double-masked, randomised, placebo-controlled, multi-centre trial.
Secondary study design	Randomised controlled trial
Scientific title	Efficacy of mechanical scaling and root planning and adjunctive chemotherapy (doxycycline hyclate 20 mg) on systemic health improvement in diabetics
Study objectives	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.
Ethics approval(s)	Research Ethics Committee, Sultan Bin Abdulaziz Humanitarian City, Riyadh, Saudi Arabia
Health condition(s) or problem(s) studied	Periodontal disease and diabetes mellitus
Intervention	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
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	doxycycline
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	500
Total final enrolment	346
Key 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
Key exclusion criteria	1. Use of antibiotics within three months prior to baseline appointment 2. Pregnant or nursing female subjects
Date of first enrolment	01/04/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

King Faisal Specialist Hospital and Research Centre

Riyadh
11536
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010	04/06/2019	Yes	No

Editorial Notes

04/06/2019: Total final enrolment and publication reference were added.