Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis
Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical 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:
- Clinical assessment.
- 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).
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
-
-
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Cairo, Egypte
- Recrutement
- Alazhar University
-
Contact:
- Doaa Abdelrazik, BDS
- Numéro de téléphone: 00201012430093 00201012430093
- E-mail: duaaabdelrazik@gmail.com
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Cairo, Egypte
- Recrutement
- Faculty of Dental Medicine for Girls, Al-Azhar University
-
Contact:
- Doaa Abdelrazik, BDS
- Numéro de téléphone: 00201012430093
- E-mail: duaaabdelrazik@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: scaling and root planning and topical insulin for stage Ⅲ periodontitis patients
Participants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets.
|
subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
|
|
Expérimental: scaling and root planning with topical application of hyaluronic acid gel
Participants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets.
|
Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
|
|
Comparateur actif: Stage III periodontitis patients
patients have stage III periodontitis
|
sub gingival scaling and root planning of periodontal pockets
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Periodontal pocket depth (PPD)
Délai: 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).
|
3-6 months
|
|
Clinical attachment loss (CAL)
Délai: 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.
|
3-6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in gingival index (GI)
Délai: 3-6 months follow up
|
(GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual).
|
3-6 months follow up
|
|
Change in bleeding on probing index (BOP)
Délai: 3-6 months follow up
|
(BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing.
|
3-6 months follow up
|
|
Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket
Délai: 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).
|
3-6 months follow up
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Plaque index (PI)
Délai: From 3 to 6 months
|
PI describe by scores according to Loe H and Sillness J.
|
From 3 to 6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OMPDR-105-2K
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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