Periodontitis
Conditions
Keywords
periodontitis, hyaluronic acid, scaling and root planning, adenosione deaminase, catalase, glutathione
Brief summary
Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in patients with periodontitis.
Detailed description
Design: A total of 24 Stage II-III periodontitis patients will be included in this split-mouth, randomized-controlled study. The study population will be divided into four groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3 (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by spectrophotometric analysis.
Interventions
PROCEDUREScaling and root planning
Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP.
DRUGHyaluronic acid gel (HA) and SRP
In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular.
DRUGHA mouthrinse and SRP
In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.
DRUGHA mouthrinse+gel and SRP
In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Systemically healthy * moderate-to-severe periodontitis * at least five sites with ≥5mm probing depth (PD) * at least ≥20 teeth * Stage II-III periodontitis according to the 2017 World Workshop * Age between18-55
Exclusion criteria
* receiving systemic or local antibiotics within the past six months * prior surgical or non-surgical periodontal treatment within the past six months * smoking * pregnancy * lactation * age ≤18 years or ≥55 years * hypertension * known chronic systemic diseases (i.e., diabetes mellitus, rheumatoid arthritis), - - known hypersensitivity to one of the ingredients of the HA preparation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical attachment level (CAL) | Change from Baseline to week 4 | as the sum of gingival recession height and probing depth will be recorded. |
| gingival index (GI) | Change from Baseline to week 4 | confirming to Silness and Löe index (Löe & Silness, 1963) |
| bleeding on probing (BOP) | Change from Baseline to week 4 | according to Ainoma and Bay (AINAMO & Bay, 1975); |
| Probing depth (PD) | Change from Baseline to week 4 | as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva; |
| gingival recession height (GRH) | Change from Baseline to week 4 | as the measurement of the distance between the marginal gingiva and cemento-enamel junction |
| plaque index | Change from Baseline to week 4 | in accordance with the Sillness and Löe index (Silness & Löe, 1964) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid | Changes from Baseline to week 1,2,4 | The ADA activity will be evaluated spectrophotometrically |
| Changes of Catalase levels in gingival crevicular fluid | Changes from Baseline to week 1,2,4 | The catalase activity will be evaluated spectrophotometrically |
| Changes of Glutathione levels in gingival crevicular fluid | Changes from Baseline to week 1,2,4 | The Glutathione activity will be evaluated spectrophotometrically |
| Changes of Periodontal inflammed surface area | Change from Baseline Baseline to week 4 | All clinical parameters will be entered on Microsoft Excel Program (www.parsprototo.info) which constructed for calculating PISA. The BOP percentage for each tooth will be calculated by entering number sites with BOP values in the Excel program. |
Countries
Turkey (Türkiye)
Outcome results
None listed