Hyaluronic Acid as an Adjunct to Non-Surgical Periodontal Therapy in Smokers
The Effect of Adjunctive Use of Hyaluronic Acid in Non-Surgical Periodontal Treatment in Smoking Patients
2 other identifiers
interventional
23
1 country
1
Brief 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 assesed 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 evaluted for Metallothionein (MT) and 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and subgingival samples for periodontal pathogens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
Study Completion
Last participant's last visit for all outcomes
July 1, 2028
May 19, 2026
May 1, 2026
2.1 years
May 13, 2026
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Baseline to 1, 3 and 6 months after NSPT.
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.
Baseline to 1, 3 and 6 months after NSPT
Secondary Outcomes (10)
Change in Bleeding on Probing (%)
Baseline to 1, 3 and 6 months after NSPT.
Change in Plaque Index
Baseline to 1, 3 and 6 months after NSPT.
Change in Gingival Index
Baseline to 1, 3 and 6 months after NSPT.
Change in GCF Metallothionein Levels
Baseline to 1, 3 and 6 months after NSPT
Change in GCF 8-OHdG levels
Baseline to 1, 3 and 6 months after NSPT
- +5 more secondary outcomes
Study Arms (2)
Test
ACTIVE COMPARATORNon-surgical periodontal treatment and Hyaluronic Acid gel
Control
OTHERNon-surgical periodontal treatment alone
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
- Participants with at least 20 natural teeth present in the mouth (excluding third molars)
- Participants in either of the jaws, in both quadrants, having two non-adjacent interproximal sites with probing depth (PD) and clinical attachment level (CAL) ≥6 mm with no caries, restorations or furcation involvement
You may not qualify if:
- 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 have received any periodontal treatment within 6 months prior to the study
- Participants who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontology, Faculty of Dentistry, Marmara University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
May 19, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05