Periodontal therapy in diabetic subjects
| ISRCTN | ISRCTN11742127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11742127 |
| Secondary identifying numbers | 005 |
- 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
Scientific
King Faisal Specialist Hospital and Research Centre
PO Box 64399
Riyadh
11536
Saudi Arabia
| Phone | +966 504180209 |
|---|---|
| salmubarak@kfshrc.edu.sa |
Study information
| Study design | A double-masked, randomised, placebo-controlled, multi-centre trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
11536
Saudi Arabia
Sponsor information
King Abdulaziz City for Science and Technology (Saudi Arabia)
Government
Government
PO Box 6068
11442
Riyadh
11536
Saudi Arabia
| Phone | +966 5620000 Ex 5019 |
|---|---|
| aasirvatham@humanitariancity.org.sa | |
| Website | http://www.kacst.edu.sa/eng/ |
"ROR" |
https://ror.org/05tdz6m39 |
Funders
Funder type
Government
King Abdulaziz City for Science and Technology, General Directorate of Research Grants Programmes (Saudi Arabia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
