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Does Hyaluronic Acid Affect Periodontal Treatment?

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

Scaling and root planning

Hyaluronic acid gel (HA) and SRP

HA mouthrinse and SRP

HA mouthrinse+gel and SRP

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, hyaluronic acid, scaling and root planning, adenosione deaminase, catalase, glutathione

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Van Yuzuncu Yil University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Scaling and root planning (SRP)

Hyaluronic acid gel (HA) and SRP

HA mouthrinse and SRP

HA mouthrinse+gel and SRP

Arm Description

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 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.

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.

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

Outcomes

Primary Outcome Measures

plaque index

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

gingival index (GI)

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

bleeding on probing (BOP)

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

Probing depth (PD)

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

gingival recession height (GRH)

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

clinical attachment level (CAL)

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

Secondary Outcome Measures

Changes of Periodontal inflammed surface area

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.

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

The ADA activity will be evaluated spectrophotometrically

Changes of Catalase levels in gingival crevicular fluid

The catalase activity will be evaluated spectrophotometrically

Changes of Glutathione levels in gingival crevicular fluid

The Glutathione activity will be evaluated spectrophotometrically

Full Information

NCT ID

NCT03754010

First Posted

November 15, 2018

Last Updated

November 23, 2018

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