Does Hyaluronic Acid Affect Periodontal Treatment?

NCT ID: NCT03754010

Last Updated: 2018-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scaling and root planning (SRP)

Under local anesthesia, full-mouth SRP was performed within 24 h in a single or two sessions using ultrasonic and hand instruments (Gracey, Hu-Friedy, Chicago, IL, USA) by a single investigator (DA). Immediately after the SRP, HA gel (Gengigel, Hyaluronic acid, gingival gel, Ricefarma S.R.L, Italy) or mouthrinse was performed according to the groups' procedure. In Group 1, the periodontal sulcus was irrigated with saline solution after SRP.

Group Type PLACEBO_COMPARATOR

Scaling and root planning

Intervention Type 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

Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular.

Group Type EXPERIMENTAL

Scaling and root planning

Intervention Type 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

Intervention Type 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.

HA mouthrinse and SRP

In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.

Group Type EXPERIMENTAL

Scaling and root planning

Intervention Type 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.

HA mouthrinse and SRP

Intervention Type DRUG

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

HA mouthrinse+gel and SRP

In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.

Group Type EXPERIMENTAL

Scaling and root planning

Intervention Type 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.

HA mouthrinse+gel and SRP

Intervention Type 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.

Interventions

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Scaling 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.

Intervention Type PROCEDURE

Hyaluronic 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.

Intervention Type DRUG

HA mouthrinse and SRP

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

Intervention Type DRUG

HA 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.

Intervention Type DRUG

Other Intervention Names

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HA and SRP HAmo+SRP HAmo+HAgel+SRP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Hacer Sahin Aydinyurt

Assist Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hacer Sahin Aydinyurt, Assist Prof

Role: STUDY_DIRECTOR

Yuzuncu Yıl University

Locations

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Van Yuzuncu Yil University Faculty of Dentistry

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 32436173 (View on PubMed)

Other Identifiers

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19.07.2017/09

Identifier Type: -

Identifier Source: org_study_id

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