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Derma Pen as Treatment of Gingivitis Induced by Orthodontics

Impact of Derma Pen in the Treatment of Gingivitis Induced by Orthodontic Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06567405
Enrollment
24
Registered
2024-08-22
Start date
2024-05-30
Completion date
2025-02-07
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Orthodontic Appliance Complication

Brief 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. 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.

Interventions

PROCEDUREmechanical periodontal treatment

Patients will undergo subgingival scaling employing a Piezoelectric ultrasonic scaler to eliminate local factors.

DEVICEDerma pen with topical ascorbic Acid

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.

Sponsors

Safa Basiouny Alawy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1. patients age: 18-25 years . 2. systemically healthy patients. 3. mild to moderate plaque-induced gingivitis patients during orthodontic therapy

Exclusion criteria

1. periodontitis. 2. individuals who smoke or those who have tobacco related habits. 3. partially edentulous individuals. 4. individuals who are diagnosed with drug-induced gingival enlargement. 5. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frameDescription
gingival index (GI)one monthgingival 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.

Secondary

MeasureTime frameDescription
Plaque Index (PI)one monthPI 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026