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Completed

NCT Number: NCT06888440

Zinc Stents for the Treatment of Gingivitis

Background This study investigates the effects of zinc-containing stents on gingival inflammation, bleeding, and plaque regrowth in gingivitis patients.

Methods A randomized, double-blind, placebo-controlled study was conducted at Çukurova University, enrolling 42 systemically healthy gingivitis patients aged 18-30. Participants were assigned to either a test group (zinc-containing stents) or a control group (placebo stents) and instructed to wear their stents for at least 12 hours daily for four weeks. Clinical measurements, including Gingival Index (GI), Plaque Index (PI), and Bleeding on Probing (BOP), were assessed at baseline, and at the 2nd, 4th, and 8th weeks. Statistical analysis was performed using IBM SPSS and RStudio.

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Key information

Conditions

Gingivitis; Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Gingival Diseases Gingivitis Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Mouth Diseases Organizing Pneumonia Periodontal Diseases Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Faculty of Dentistry

Adana, 01130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of plaque-induced gingivitis [bleeding on gentle probing at >30% of sites examined and a gingival index (GI) of at least 1 at >60% of sites examined],
  • Plaque index (PI) of ≥ 2 according to the modified Quigley&Hein index,
  • 18-30 years old,
  • At least 20 natural teeth,
  • Systemically healthy.

Exclusion criteria

  • Pocket probing depth (PPD) of ≥4 mm,
  • Interdental clinical attachment loss (CAL) detectable at ≥2 nonadjacent teeth or displaying buccal/oral CAL ≥3 mm coupled with PD ≥3 mm
  • Subjects with a history of allergies to Zinc,
  • The presence of hematologic disorders or any other systemic illness,
  • Pregnancy and breastfeeding,
  • Current orthodontic treatment,
  • History of periodontal therapy,
  • Use of antibiotics or anti-inflammatory medication within the preceding 6 months,
  • Smoking.

Treatment and study plan

scaling and zinc stents

Procedure

this group will receive scaling and zinc containing stents

scaling and placebo stents

Procedure

this group will receive scaling and placebo stents

Primary outcomes

  1. Gingival index

    Time frame: Baseline, 2nd week, 4th week, 8th week

    0- Normal gingiva;

    • Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing;
    • Moderate inflammation with edema, redness, swelling and bleeding on probing;
    • Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.

Secondary outcomes

  1. Plaque index

    Time frame: Baseline, 2nd week, 4th week, 8th week

    0- No plaque;

    • Separate spots of plaque at the cervical margin of the tooth;
    • A thin, continuous band of plaque at the cervical margin;
    • A band of plaque wider than 1 mm but covering less than one-third of the tooth; 4 - plaque covering more than one-third and less than two-thirds of thecrown;
    • Plaque covering more than two thirds of the crown.

  2. Bleeding on probing

    Time frame: Baseline, 2nd week, 4th week, 8th week

    The bleeding on probing was be measured by using a periodontal probe at six sites per tooth and will be recorded as (+) or (-).

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Clinical Effects of Zinc-containing Stents on Gingivitis: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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