NCT06888440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 14, 2025

Last Update Submit

March 20, 2025

Conditions

Gingivitis; Chronic

Keywords

gingivitiszinctreatment

Outcome Measures

Primary Outcomes (1)

  • Gingival index

    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.

    Baseline, 2nd week, 4th week, 8th week

Secondary Outcomes (2)

  • Plaque index

    Baseline, 2nd week, 4th week, 8th week

  • Bleeding on probing

    Baseline, 2nd week, 4th week, 8th week

Study Arms (2)

zinc containing stent

EXPERIMENTAL

This group will use zinc containing stent after scaling.

Procedure: scaling and zinc stents

placebo stent

PLACEBO COMPARATOR

This group will use placebo stent after scaling.

Procedure: scaling and placebo stents

Interventions

scaling and zinc stentsPROCEDURE

this group will receive scaling and zinc containing stents

zinc containing stent
scaling and placebo stentsPROCEDURE

this group will receive scaling and placebo stents

placebo stent

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • years old,
  • At least 20 natural teeth,
  • Systemically healthy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Dentistry

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (1)

  • Alkaya B, Kayhan HG, Demirbilek F, Sahin M, Totik N, Ozcan M, Teughels W. Clinical Effects of Zinc-containing Stents on Gingivitis: A Randomised Controlled Trial. Oral Health Prev Dent. 2025 Sep 26;23:577-584. doi: 10.3290/j.ohpd.c_2275.

    PMID: 41001958DERIVED

MeSH Terms

Conditions

GingivitisBronchiolitis Obliterans Syndrome

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Mehmet Cenk Haytac, Professor

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 21, 2025

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

February 28, 2025

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)