GingivitisNCT06567405
Derma Pen as Treatment of Gingivitis Induced by Orthodontics
A study testing mechanical periodontal treatment and Derma pen with topical ascorbic Acid in people with Gingivitis and Orthodontic Appliance Complication, run by Safa Basiouny Alawy at 1 site in Egypt.
Trial summary
Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Gingivitis, Orthodontic Appliance Complication
- What is being tested?
- mechanical periodontal treatment and Derma pen with topical ascorbic Acid
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to 7 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients age: 18-25 years .
- systemically healthy patients.
- mild to moderate plaque-induced gingivitis patients during orthodontic therapy
Who cannot join
- periodontitis.
- individuals who smoke or those who have tobacco related habits.
- partially edentulous individuals.
- individuals who are diagnosed with drug-induced gingival enlargement.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Derma Pen in the Treatment of Gingivitis Induced by Orthodontic Therapy
Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Ascorbic acid and Derma Pen used together have recently surfaced as a potentially effective therapy option for patients who seeking for periodontal therapy during and after orthodontic treatments.
- Conditions
- Gingivitis, Orthodontic Appliance Complication
- Being tested
- mechanical periodontal treatment, Derma pen with topical ascorbic Acid
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical periodontal treatmentProcedure or surgery
Patients will undergo subgingival scaling employing a Piezoelectric ultrasonic scaler to eliminate local factors.
Derma pen with topical ascorbic AcidDevice
local anesthesia of 2% lignocaine will be administered by infiltration technique in the anterior maxillary region. Microneedling of the mucosa will be performed using dermapen needles, employing an intermittent back-and-forth motion in the anterior maxillary and mandibular region for 30-40 seconds, reaching a depth of 1.5 mm. This will involve the creation of microholes in the gingival tissue using derma pen to enhance the concentration and penetration of the ascorbic Acid through the gingival tissues.
| Study group | Role | What they receive |
|---|---|---|
| group I: dermapen and topical ascorbic Acid | Experimental | 12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid Receives: Device: Derma pen with topical ascorbic Acid |
| group II: mechanical periodontal treatment | Active comparator | 12 individuals who have orthodontically induced gingivitis will receive mechanical periodontal treatment only Receives: Procedure: mechanical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index (GI)
gingival index will be calibrated using William's probe approximately 1 to 2 mm to the margin of the gingiva at an angulation of 45 degree to document the gingival inflammation signs of the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate GI of each tooth.
Score 0 = No signs of inflammation, bleeding, or swelling. Score 1= Presence of signs of mild inflammation, slight edema, and color change but no bleeding.
Score 2 = Presence of moderate inflammation, redness, swelling, and bleeding on probing.
Score 3 = Presence of severe inflammation, marked redness, edema, and spontaneous bleeding.
Measured: one month
Secondary outcomes (1)
Plaque Index (PI)
PI will be measured to record soft deposit accumulations on the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate PI of each tooth.
Sore 0 = No plaque. Score 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after using the probe on the tooth surface (not seen by the naked eye).
Score 2 = Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
Score 3 = Abundance of soft deposits within the gingival pocket and/or on the tooth and gingival margin that covers the interdental areas.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start30 May 2024
- Primary completion1 Dec 2024
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Safa Basiouny Alawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safa Basiouny Alawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567405
- Sponsor's protocol ID
- #R-OMPDR-5-24-3111
- Status last verified
- May 2025
- First submitted
- 21 Aug 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Derma Pen in the Treatment of Gingivitis Induced by Orthodontic Therapy
- ClinicalTrials.gov ID
- NCT06567405
- Acronym / sponsor ID
- #R-OMPDR-5-24-3111
- Conditions
- Gingivitis, Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Safa Basiouny AlawyUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 22 Aug 2024 (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.
Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Ascorbic acid and Derma Pen used together have recently surfaced as a potentially effective therapy option for patients who seeking for periodontal therapy during and after orthodontic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I: dermapen and topical ascorbic Acid | Experimental | Device: Derma pen with topical ascorbic Acid12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid |
| group II: mechanical periodontal treatment | Active comparator | Procedure: mechanical periodontal treatment12 individuals who have orthodontically induced gingivitis will receive mechanical periodontal treatment only |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients age: 18-25 years .
- systemically healthy patients.
- mild to moderate plaque-induced gingivitis patients during orthodontic therapy
Key exclusion criteria (5 listed)
- periodontitis.
- individuals who smoke or those who have tobacco related habits.
- partially edentulous individuals.
- individuals who are diagnosed with drug-induced gingival enlargement.
- Pregnant or lactating women
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 |
|---|---|---|
| mechanical periodontal treatmentPatients will undergo subgingival scaling employing a Piezoelectric ultrasonic scaler to eliminate local factors. | Procedure or surgery | group II: mechanical periodontal treatment |
| Derma pen with topical ascorbic Acidlocal anesthesia of 2% lignocaine will be administered by infiltration technique in the anterior maxillary region. Microneedling of the mucosa will be performed using dermapen needles, employing an intermittent back-and-forth motion in the anterior maxillary and mandibular region for 30-40 seconds, reaching a depth of 1.5 mm. This will involve the creation of microholes in the gingival tissue using derma pen to enhance the concentration and penetration of the ascorbic Acid through the gingival tissues. | Device | group I: dermapen and topical ascorbic Acid |
Primary outcome
gingival index (GI)
Time frame: one month
gingival index will be calibrated using William's probe approximately 1 to 2 mm to the margin of the gingiva at an angulation of 45 degree to document the gingival inflammation signs of the upper six anterior teeth. Each of the four surfaces of the anterior teeth (buccal, lingual, mesial, and distal) will be given a score from 0 to 3 and then areas were added and divided by four to give the accurate GI of each tooth. Score 0 = No signs of inflammation, bleeding, or swelling. Score 1= Presence of signs of mild inflammation, slight edema, and color change but no bleeding. Score 2 = Presence of moderate inflammation, redness, swelling, and bleeding on probing. Score 3 = Presence of severe inflammation, marked redness, edema, and spontaneous bleeding.
1 secondary outcome
Plaque Index (PI)
Time frame: one month
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 13 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical periodontal treatment and Derma pen with topical ascorbic Acid in people with Gingivitis and Orthodontic Appliance Complication, run by Safa Basiouny Alawy at 1 site in Egypt.
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 3 inclusion and 5 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 13 May 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 Egypt. 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. 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 (GI) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.