Does Hyaluronic Acid Affect Periodontal Treatment?

NCT03754010 | Completed Phase 1

• 1 other identifier: 19.07.2017/09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; hyaluronic acid; scaling and root planning; adenosione deaminase; catalase; glutathione

Outcome Measures

Primary Outcomes (6)

• plaque index

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

  Change from Baseline to week 4

• gingival index (GI)

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

  Change from Baseline to week 4

• bleeding on probing (BOP)

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

  Change from Baseline to week 4

• Probing depth (PD)

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

  Change from Baseline to week 4

• gingival recession height (GRH)

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

  Change from Baseline to week 4

• clinical attachment level (CAL)

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

  Change from Baseline to week 4

Secondary Outcomes (4)

• Changes of Periodontal inflammed surface area

  Change from Baseline Baseline to week 4

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

  Changes from Baseline to week 1,2,4

• Changes of Catalase levels in gingival crevicular fluid

  Changes from Baseline to week 1,2,4

• Changes of Glutathione levels in gingival crevicular fluid

  Changes from Baseline to week 1,2,4

Study Arms (4)

Scaling and root planning (SRP)

PLACEBO COMPARATOR

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.

Procedure: Scaling and root planning

Hyaluronic acid gel (HA) and SRP

EXPERIMENTAL

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.

Procedure: Scaling and root planning; Drug: Hyaluronic acid gel (HA) and SRP

HA mouthrinse and SRP

EXPERIMENTAL

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.

Procedure: Scaling and root planning; Drug: HA mouthrinse and SRP

HA mouthrinse+gel and SRP

EXPERIMENTAL

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

Procedure: Scaling and root planning; Drug: HA mouthrinse+gel and SRP

Interventions

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.

HA mouthrinse and SRP; HA mouthrinse+gel and SRP; Hyaluronic acid gel (HA) and SRP; Scaling and root planning (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.

Also known as: HA and SRP

Hyaluronic acid gel (HA) and SRP

HA mouthrinse and SRP DRUG

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

Also known as: HAmo+SRP

HA mouthrinse and 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.

Also known as: HAmo+HAgel+SRP

HA mouthrinse+gel and SRP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32436173 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Hacer Sahin Aydinyurt, Assist Prof

  Yuzuncu Yil University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 27, 2018
• Study Start: August 30, 2017
• Primary Completion: April 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

TU (1)