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OpenTrials
Completed

NCT Number: NCT06567405

Derma Pen as Treatment of Gingivitis Induced by Orthodontics

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Orthodontic Appliance Complication Periodontal Diseases Stomatognathic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, 6624033, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

mechanical periodontal treatment

Procedure

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

Derma pen with topical ascorbic Acid

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: one month

    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.

Sponsors and collaborators

Lead sponsor

Safa Basiouny Alawy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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