Contact information
Type
Scientific
Primary contact
Dr Sultan Al Mubarak
ORCID ID
Contact details
King Faisal Specialist Hospital and Research Centre
PO Box 64399
Riyadh
11536
Saudi Arabia
+966 504180209
salmubarak@kfshrc.edu.sa
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
005
Study information
Scientific title
Efficacy of mechanical scaling and root planning and adjunctive chemotherapy (doxycycline hyclate 20 mg) on systemic health improvement in diabetics
Acronym
Study hypothesis
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
Research Ethics Committee, Sultan Bin Abdulaziz Humanitarian City, Riyadh, Saudi Arabia
Study design
A double-masked, randomised, placebo-controlled, multi-centre trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
doxycycline
Primary outcome measure
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 outcome measures
No secondary outcome measures
Overall trial start date
01/04/2006
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Total final enrolment
346
Participant exclusion criteria
1. Use of antibiotics within three months prior to baseline appointment
2. Pregnant or nursing female subjects
Recruitment start date
01/04/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Faisal Specialist Hospital and Research Centre
Riyadh
11536
Saudi Arabia
Sponsor information
Organisation
King Abdulaziz City for Science and Technology (Saudi Arabia)
Sponsor details
PO Box 6068
11442
Riyadh
11536
Saudi Arabia
+966 5620000 Ex 5019
aasirvatham@humanitariancity.org.sa
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
King Abdulaziz City for Science and Technology, General Directorate of Research Grants Programmes (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: https://doi.org/10.1016/j.ijdm.2010.08.006 (added 04/06/2019)