Condition category
Oral Health
Date applied
12/06/2008
Date assigned
25/06/2008
Last edited
25/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

http://www.kacst.edu.sa/eng/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes