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PeriodontitisPhase 1NCT03754010

Does Hyaluronic Acid Affect Periodontal Treatment?

A Phase 1 study testing Scaling and root planning, Hyaluronic acid gel (HA) and SRP and HA mouthrinse and SRP in people with Periodontitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Periodontitis
What is being tested?
Scaling and root planning, Hyaluronic acid gel (HA) and SRP and HA mouthrinse and SRP
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Aug 2017to 30 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Van Yuzuncu Yil University Faculty of Dentistry

    Van, 65080

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Periodontitis
Being tested
Scaling and root planning, Hyaluronic acid gel (HA) and SRP, HA mouthrinse and SRP, HA mouthrinse+gel and SRP
Keywords
periodontitis, hyaluronic acid, scaling and root planning, adenosione deaminase, catalase, glutathione
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scaling and root planningProcedure or surgery

    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 SRPDrug

    Also called 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.

  • HA mouthrinse and SRPDrug

    Also called HAmo+SRP

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

  • HA mouthrinse+gel and SRPDrug

    Also called HAmo+HAgel+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.

Study groups in NCT03754010
Study groupRoleWhat they receive
Scaling and root planning (SRP)Placebo comparatorUnder 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.
Receives: Procedure: Scaling and root planning
Hyaluronic acid gel (HA) and SRPExperimentalGroup 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.
Receives: Procedure: Scaling and root planning; Drug: Hyaluronic acid gel (HA) and SRP
HA mouthrinse and SRPExperimentalIn Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.
Receives: Procedure: Scaling and root planning; Drug: HA mouthrinse and SRP
HA mouthrinse+gel and SRPExperimentalIn Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.
Receives: Procedure: Scaling and root planning; Drug: HA mouthrinse+gel and SRP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. plaque index

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

    Measured: Change from Baseline to week 4

  2. gingival index (GI)

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

    Measured: Change from Baseline to week 4

  3. bleeding on probing (BOP)

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

    Measured: Change from Baseline to week 4

  4. Probing depth (PD)

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

    Measured: Change from Baseline to week 4

  5. gingival recession height (GRH)

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

    Measured: Change from Baseline to week 4

  6. clinical attachment level (CAL)

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

    Measured: Change from Baseline to week 4

Secondary outcomes (4)

  1. 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.

    Measured: Change from Baseline Baseline to week 4

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

    The ADA activity will be evaluated spectrophotometrically

    Measured: Changes from Baseline to week 1,2,4

  3. Changes of Catalase levels in gingival crevicular fluid

    The catalase activity will be evaluated spectrophotometrically

    Measured: Changes from Baseline to week 1,2,4

  4. Changes of Glutathione levels in gingival crevicular fluid

    The Glutathione activity will be evaluated spectrophotometrically

    Measured: Changes from Baseline to week 1,2,4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start30 Aug 2017
  3. Primary completion30 Apr 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03754010
Sponsor's protocol ID
19.07.2017/09
Status last verified
Nov 2018
First submitted
15 Nov 2018
Last updated
27 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32436173

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Scaling and root planning, Hyaluronic acid gel (HA) and SRP and HA mouthrinse and SRP in people with Periodontitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

plaque index (time frame: Change from Baseline to week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03754010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.

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