Derma Pen as Treatment of Gingivitis Induced by Orthodontics

Not Applicable

Completed

• Conditions: Orthodontic Appliance Complication; Gingivitis
• Interventions: Procedure: mechanical periodontal treatment; Device: Derma pen with topical ascorbic Acid

• Registration Number: NCT06567405
• Lead Sponsor: Safa Basiouny Alawy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-22
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group II: mechanical periodontal treatment	mechanical periodontal treatment	12 individuals who have orthodontically induced gingivitis will receive mechanical periodontal treatment only
group I: dermapen and topical ascorbic Acid	Derma pen with topical ascorbic Acid	12 individuals who have orthodontically induced gingivitis will be treated with dermapen and topical ascorbic Acid

Primary Outcome Measures

Name	Time	Method
gingival index (GI)	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 Outcome Measures

Name	Time	Method
Plaque Index (PI)	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt