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

Condition(s) studied

Investigational drug(s) / intervention(s)

Scaling and Root Planing: 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): 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.

Study summary

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

Primary outcome measure(s)

• Change in Probing Depth (PD) — Baseline to 1, 3 and 6 months after NSPT.
  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)
• Change in Clinical Attachment Level — Baseline to 1, 3 and 6 months after NSPT
  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.

Trial sites (1)

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