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).
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Cairo, Egypten
- Rekruttering
- Alazhar University
-
Kontakt:
- Doaa Abdelrazik, BDS
- Telefonnummer: 00201012430093 00201012430093
- E-mail: duaaabdelrazik@gmail.com
-
Cairo, Egypten
- Rekruttering
- Faculty of Dental Medicine for Girls, Al-Azhar University
-
Kontakt:
- Doaa Abdelrazik, BDS
- Telefonnummer: 00201012430093
- E-mail: duaaabdelrazik@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
|
|
Eksperimentel: 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.
|
|
Aktiv komparator: Stage III periodontitis patients
patients have stage III periodontitis
|
sub gingival scaling and root planning of periodontal pockets
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Periodontal pocket depth (PPD)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in gingival index (GI)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plaque index (PI)
Tidsramme: From 3 to 6 months
|
PI describe by scores according to Loe H and Sillness J.
|
From 3 to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMPDR-105-2K
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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