Treatment of Stage III Periodontitis, Local Application of Insulin in Pockets
Conditions
Brief summary
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients. This will be done by: 1. Clinical assessment. 2. Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets. C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket. O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket. Study type: Randomized controlled trials (RCTs).
Detailed description
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program. The randomization of patients will form the following 3 groups: Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone. Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP. Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
Interventions
DRUGInsulin
subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
PROCEDUREmechanical debridement
sub gingival scaling and root planning of periodontal pockets
Sponsors
Doaa Atta Aid
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index. * Should be diagnosed as having periodontitis. * Not received any type of periodontal treatment in the past 6 months prior to examination. * Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits. * Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Exclusion criteria
* Antibiotic therapy in the preceding 6 months or during study participation. * History of insulin dependent diabetes and thyroid disease. * Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug. * Poor oral hygiene compliance or inability to adhere to the clinical protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal pocket depth (PPD) | 3-6 months | (PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions). |
| Clinical attachment loss (CAL) | 3-6 months | (CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival index (GI) | 3-6 months follow up | (GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual). |
| Change in bleeding on probing index (BOP) | 3-6 months follow up | (BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing. |
| Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket | 3-6 months follow up | Using the Bioassay Technology Laboratory IL-1β ELISA kit to determine levels of IL-1β in (GCF) using enzyme-linked immunosorbent assay (ELISA). |
Countries
Egypt
Outcome results
None listed