Derma Pen as Treatment of Gingivitis Induced by Orthodontics

NCT06567405 | Completed DMC

• 1 other identifier: #R-OMPDR-5-24-3111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plaque Index (PI)

  one month

Study Arms (2)

group I: dermapen and topical ascorbic Acid

EXPERIMENTAL

12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid

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

Procedure: mechanical periodontal treatment

Interventions

mechanical periodontal treatment PROCEDURE

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

group II: mechanical periodontal treatment

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.

group I: dermapen and topical ascorbic Acid

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Safa Basiouny Alawy: lead

Study Sites (1)

Tanta University

Tanta, Tanta, 6624033, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Orthodontics

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 22, 2024
• Study Start: May 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 7, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

EG (1)