Zinc Stents for the Treatment of Gingivitis

Çukurova University

Status: Completed

Conditions: Gingivitis; Chronic

Treatments: Procedure: scaling and zinc stents; Procedure: scaling and placebo stents

Study type: Interventional

Funder types: Other

Identifiers

NCT06888440

CukurovaU-dhf12

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

zinc containing stent

Experimental group

Description:

This group will use zinc containing stent after scaling.

Treatment:

Procedure: scaling and zinc stents

placebo stent

Placebo Comparator group

Description:

This group will use placebo stent after scaling.

Treatment:

Procedure: scaling and placebo stents