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Zinc Stents for the Treatment of Gingivitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06888440
Enrollment
42
Registered
2025-03-21
Start date
2023-10-01
Completion date
2025-02-28
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis; Chronic

Keywords

gingivitis, zinc, treatment

Brief summary

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.

Interventions

PROCEDUREscaling and zinc stents

this group will receive scaling and zinc containing stents

PROCEDUREscaling and placebo stents

this group will receive scaling and placebo stents

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gingival indexBaseline, 2nd week, 4th week, 8th week0- Normal gingiva; 1. Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing; 2. Moderate inflammation with edema, redness, swelling and bleeding on probing; 3. Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.

Secondary

MeasureTime frameDescription
Plaque indexBaseline, 2nd week, 4th week, 8th week0- No plaque; 1. Separate spots of plaque at the cervical margin of the tooth; 2. A thin, continuous band of plaque at the cervical margin; 3. 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; 4. Plaque covering more than two thirds of the crown.
Bleeding on probingBaseline, 2nd week, 4th week, 8th weekThe bleeding on probing was be measured by using a periodontal probe at six sites per tooth and will be recorded as (+) or (-).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026