Hyaluronic Acid as an Adjunct to Non-Surgical Periodontal Therapy in Smokers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University

About this trial

The goal of this clinical trial is to evaluate whether hyaluronic acid (HA) improves periodontal healing in people with periodontal disease who smoke. Moreover, the effects of HA on biomolecules and bacteria levels will be assessed during the follow up period.

The main questions it will answer are:

Will periodontal sites treated with HA gel after non-surgical periodontal treatment (NSPT) lead to better outcomes in clinical parameters compared to the sites treated with NSPT only in smokers?

Will adjunctive use of HA gel reduce oxidative stress markers and bacteria levels during follow-up?

Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits.

Participants will:

* first receive full-mouth NSPT then, randomization will be performed in selected jaw to determine the test sites. These two interproximal test sites will additionally receive HA gel application. * attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples.

The GCF samples will be evaluated for Metallothionein (MT) and 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and subgingival samples for periodontal pathogens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who sign the informed consent form

Participants who are systemically healthy

Participants who smoke (for >5 years and ≥10 cigarettes per day)

Participants diagnosed with Stage III or Stage IV periodontitis

Disqualifiers

Individuals who do not sign the informed consent form

Individuals having any systemic disease

Participants who have used antibiotics within the last 3 months

Participants who have received any periodontal treatment within 6 months prior to the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scaling and Root Planing

    Procedure/Surgery

    Scaling and root planing is a conventional gold-standard treatment for periodontitis. As part of this procedure, subgingival plaque and tartar are removed and root surfaces are planed.

  • Hyaluronic Acid (HYADENT BG)

    Device

    Hyaluronic acid will be locally applied to periodontal pockets as an adjunct to non-surgical periodontal treatment, aiming to support periodontal healing. After completion of scaling and root planing, the material will be delivered subgingivally to designated test sites.

Treatment groups

23 Participants
are divided into 2 treatment groups
Group A: TestActive comparator 2 interventions
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Probing Depth (PD)

PD will be measured around each tooth by recording the distance in milimeters from the gingival margin to the bottom of the pocket at 6 locations (mesiobuccal, mid-buccal, distobuccal, mesiopalatal, mid-palatal, distopalatal)

Time frame
Baseline to 1, 3 and 6 months after NSPT.
2

Change in Clinical Attachment Level

Clinical attachment level will be measured in millimeters using a periodontal probe. The change in CAL will be calculated as the difference between baseline and follow-up measurements. A decrease in CAL indicates an improvement in periodontal attachment.

Time frame
Baseline to 1, 3 and 6 months after NSPT

Secondary outcomes

1

Change in Bleeding on Probing (%)

Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.

Time frame
Baseline to 1, 3 and 6 months after NSPT.
2

Change in Plaque Index

Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome

Time frame
Baseline to 1, 3 and 6 months after NSPT.
3

Change in Gingival Index

Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome

Time frame
Baseline to 1, 3 and 6 months after NSPT.
4

Change in GCF Metallothionein Levels

Change in metallothionein levels from baseline to 1, 3 and 6 months after NSPT

Time frame
Baseline to 1, 3 and 6 months after NSPT

Other outcomes

Sponsors and contacts

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