Zinc Stents for the Treatment of Gingivitis

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Chronic
• Intervention / Treatment: Procedure: scaling and zinc stents; Procedure: scaling and placebo stents

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01130
    • Cukurova university Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zinc containing stent; This group will use zinc containing stent after scaling.	Procedure: scaling and zinc stents; this group will receive scaling and zinc containing stents
Placebo Comparator: placebo stent; This group will use placebo stent after scaling.	Procedure: scaling and placebo stents; this group will receive scaling and placebo stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	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.	Baseline, 2nd week, 4th week, 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	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.	Baseline, 2nd week, 4th week, 8th week
Bleeding on probing	The bleeding on probing was be measured by using a periodontal probe at six sites per tooth and will be recorded as (+) or (-).	Baseline, 2nd week, 4th week, 8th week

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Mehmet Cenk Haytac, Professor, Cukurova university

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: treatment; zinc; gingivitis
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis
• Other Study ID Numbers: CukurovaU-dhf12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No