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Completed

NCT Number: NCT03754010

Does Hyaluronic Acid Affect Periodontal Treatment?

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Van Yuzuncu Yil University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and root planning

Procedure

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.

Hyaluronic acid gel (HA) and SRP

Drug

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.

Other names: HA and SRP

HA mouthrinse and SRP

Drug

In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.

Other names: HAmo+SRP

HA mouthrinse+gel and SRP

Drug

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.

Other names: HAmo+HAgel+SRP

Primary outcomes

  1. plaque index

    Time frame: Change from Baseline to week 4

    in accordance with the Sillness and Löe index (Silness & Löe, 1964)

  2. gingival index (GI)

    Time frame: Change from Baseline to week 4

    confirming to Silness and Löe index (Löe & Silness, 1963)

  3. bleeding on probing (BOP)

    Time frame: Change from Baseline to week 4

    according to Ainoma and Bay (AINAMO & Bay, 1975);

  4. Probing depth (PD)

    Time frame: Change from Baseline to week 4

    as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva;

  5. gingival recession height (GRH)

    Time frame: Change from Baseline to week 4

    as the measurement of the distance between the marginal gingiva and cemento-enamel junction

  6. clinical attachment level (CAL)

    Time frame: Change from Baseline to week 4

    as the sum of gingival recession height and probing depth will be recorded.

Secondary outcomes

  1. Changes of Periodontal inflammed surface area

    Time frame: 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.

  2. Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid

    Time frame: Changes from Baseline to week 1,2,4

    The ADA activity will be evaluated spectrophotometrically

  3. Changes of Catalase levels in gingival crevicular fluid

    Time frame: Changes from Baseline to week 1,2,4

    The catalase activity will be evaluated spectrophotometrically

  4. Changes of Glutathione levels in gingival crevicular fluid

    Time frame: Changes from Baseline to week 1,2,4

    The Glutathione activity will be evaluated spectrophotometrically

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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