Derma Pen as Treatment of Gingivitis Induced by Orthodontics

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Orthodontic Appliance Complication
• Intervention / Treatment: Device: Derma pen with topical ascorbic Acid; Procedure: mechanical periodontal treatment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 6624033
    • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I: dermapen and topical ascorbic Acid; 12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid	Device: Derma 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.
Active Comparator: group II: mechanical periodontal treatment; 12 individuals who have orthodontically induced gingivitis will receive mechanical periodontal treatment only	Procedure: mechanical periodontal treatment; Patients will undergo subgingival scaling employing a Piezoelectric ultrasonic scaler to eliminate local factors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one month

Collaborators and Investigators

• Sponsor: Safa Basiouny Alawy

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Antioxidants; Protective Agents; Vitamins; Ascorbic Acid
• Other Study ID Numbers: #R-OMPDR-5-24-3111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No