Zinc Stents for the Treatment of Gingivitis

Not Applicable

Completed

• Conditions: Gingivitis; Chronic

• Registration Number: NCT06888440
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-04-01
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival index	Baseline, 2nd week, 4th week, 8th week	0- 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 Outcome Measures

Name	Time	Method
Plaque index	Baseline, 2nd week, 4th week, 8th week	0- 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 probing	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 (-).

Trial Locations

Locations (1)

Cukurova University Faculty of Dentistry; 🇹🇷 Adana, Turkey