Clinical trial NCT03754010: Does Hyaluronic Acid Affect Periodontal Treatment?
Official title: Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontitis
Keywords: periodontitis
hyaluronic acid
scaling and root planning
adenosione deaminase
catalase
glutathione
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: plaque index
timeFrame: Change from Baseline to week 4
measure: gingival index (GI)
timeFrame: Change from Baseline to week 4
measure: bleeding on probing (BOP)
timeFrame: Change from Baseline to week 4
measure: Probing depth (PD)
timeFrame: Change from Baseline to week 4
measure: gingival recession height (GRH)
timeFrame: Change from Baseline to week 4
measure: clinical attachment level (CAL)
timeFrame: Change from Baseline to week 4
Secondary outcomes:
measure: Changes of Periodontal inflammed surface area
timeFrame: Change from Baseline Baseline to week 4
measure: Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid
timeFrame: Changes from Baseline to week 1,2,4
measure: Changes of Catalase levels in gingival crevicular fluid
timeFrame: Changes from Baseline to week 1,2,4
measure: Changes of Glutathione levels in gingival crevicular fluid
timeFrame: Changes from Baseline to week 1,2,4
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yuzuncu Yil University Faculty of Dentistry
Study officials:
affiliation: Yuzuncu Yıl University
name: Hacer Sahin Aydinyurt, Assist Prof
role: STUDY_DIRECTOR
References:
citation: Aydinyurt HS, Akbal D, Altindal D, Bozoglan A, Ertugrul AS, Demir H. Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial. Ir J Med Sci. 2020 Nov;189(4):1485-1494. doi: 10.1007/s11845-020-02230-6. Epub 2020 May 21.