Gingivitis; ChronicNCT06888440
Zinc Stents for the Treatment of Gingivitis
A study testing scaling and zinc stents in people with Gingivitis; Chronic, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis; Chronic
- What is being tested?
- scaling and zinc stents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- History of periodontal therapy,
- Use of antibiotics or anti-inflammatory medication within the preceding 6 months,
- Smoking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana, 01130
About this study
Official title: 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.
- Conditions
- Gingivitis; Chronic
- Being tested
- scaling and zinc stents, scaling and placebo stents
- Keywords
- gingivitis, zinc, treatment
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and zinc stentsProcedure or surgery
this group will receive scaling and zinc containing stents
scaling and placebo stentsProcedure or surgery
this group will receive scaling and placebo stents
| Study group | Role | What they receive |
|---|---|---|
| zinc containing stent | Experimental | This group will use zinc containing stent after scaling. Receives: Procedure: scaling and zinc stents |
| placebo stent | Placebo comparator | This group will use placebo stent after scaling. Receives: Procedure: scaling and placebo stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2nd week, 4th week, 8th week
Secondary outcomes (2)
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.
Measured: 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 (-).
Measured: Baseline, 2nd week, 4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingivitis; ChronicStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Haytac, Cukurova University
- Investigators
- Mehmet Cenk Haytac, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888440
- Sponsor's protocol ID
- CukurovaU-dhf12
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41001958
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Zinc-containing Stents on Gingivitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06888440
- Acronym / sponsor ID
- CukurovaU-dhf12
- Conditions
- Gingivitis; Chronic
- Keywords
- gingivitis, zinc, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc containing stent | Experimental | Procedure: scaling and zinc stentsThis group will use zinc containing stent after scaling. |
| placebo stent | Placebo comparator | Procedure: scaling and placebo stentsThis group will use placebo stent after scaling. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scaling and zinc stentsthis group will receive scaling and zinc containing stents | Procedure or surgery | zinc containing stent |
| scaling and placebo stentsthis group will receive scaling and placebo stents | Procedure or surgery | placebo stent |
Primary outcome
Gingival index
Time frame: 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.
2 secondary outcomes
Plaque index
Time frame: Baseline, 2nd week, 4th week, 8th week
Bleeding on probing
Time frame: Baseline, 2nd week, 4th week, 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41001958Alkaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Cenk Haytac, Professor principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and zinc stents in people with Gingivitis; Chronic, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: Baseline, 2nd week, 4th week, 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.