Zinc Stents for the Treatment of Gingivitis

NCT ID: NCT06888440

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-02-28

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.

Conditions

Gingivitis; Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

zinc containing stent

This group will use zinc containing stent after scaling.

Group Type: EXPERIMENTAL

scaling and zinc stents

Intervention Type: PROCEDURE

this group will receive scaling and zinc containing stents

placebo stent

This group will use placebo stent after scaling.

Group Type: PLACEBO_COMPARATOR

scaling and placebo stents

Intervention Type: PROCEDURE

this group will receive scaling and placebo stents

Interventions

scaling and zinc stents

this group will receive scaling and zinc containing stents

Intervention Type: PROCEDURE

scaling and placebo stents

this group will receive scaling and placebo stents

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Cenk Haytac

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Cenk Haytac, Professor

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

Cukurova University Faculty of Dentistry

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 41001958 (View on PubMed)

Other Identifiers

CukurovaU-dhf12

Identifier Type: -

Identifier Source: org_study_id