Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis

ConditionsTreatment of Stage III Periodontitis Local Application of Insulin in Pockets

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorDoaa Atta Aid

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Insulin
Drug
subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
Hyaluronic acid gel
Drug
Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
mechanical debridement
Procedure/Surgery
sub gingival scaling and root planning of periodontal pockets

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: scaling and root planning and topical insulin for stage Ⅲ periodontitis patientsActive comparator 1 intervention

Group B: scaling and root planning with topical application of hyaluronic acid gelExperimental treatment 1 intervention

Group C: Stage III periodontitis patientsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Periodontal pocket depth (PPD)

(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).

Time frame

3-6 months

Clinical attachment loss (CAL)

(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.

Time frame

3-6 months

Secondary outcomes

Change in gingival index (GI)

(GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual).

Time frame

3-6 months follow up

Change in bleeding on probing index (BOP)

(BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing.

Time frame

3-6 months follow up

Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket

Using the Bioassay Technology Laboratory IL-1β ELISA kit to determine levels of IL-1β in (GCF) using enzyme-linked immunosorbent assay (ELISA).

Time frame

3-6 months follow up

Other outcomes

Plaque index (PI)

PI describe by scores according to Loe H and Sillness J.

Time frame

From 3 to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Doaa Atta Aid

Lead sponsor

Faculty of Dental Medicine for Girls

Sponsor institution

Al-Azhar University

Collaborator

Source ClinicalTrials.gov

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