NCT07067515

Effectiveness of Omega-3 Poly Unsaturated Fatty Acids on The Treatment of Gingival Hyperpigmentation

Effectiveness of Omega-3 Poly Unsaturated Fatty Acids on The Treatment of Gingival Hyperpigmentation: A Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This new study compares the effectiveness of scalpel surgery and omega-3 poly unsaturated fatty acid (PUF) injections in treating gingival hyperpigmentation.

Detailed description

Thirty patients complaining from gingival hyperpigmentation will be involved in this study. 30 patients will be divided into two groups each group will be randomly allocated into: Group(I) will be treated with intra-gingival tissue injection of 1-2grams of Omega-3 (PUFAs) every week. In addition to administering a daily dosage of two gram of Omega-3 (PUF) both prior to and following surgery. The second group (II) will be treated with surgical conventional technique to remove hyperpigmentation. Patients with mild to moderate hyperpigmented gingiva who are selected with maxillary esthetic area. Hyperpigmentation will be followed up at baseline, one month, 3 months and six months.

Conditions

• Hyperpigmentation
• Gingival Hyperpigmentaion

Interventions

Type	Name	Description
COMBINATION_PRODUCT	non surgical with PUFA injection	The hyperpigmented gingiva in the canine/1st premolar region to the contralateral comparable tooth region in the maxillary aesthetic areas will be the target area for this procedure. A local anesthesia will be used to numb the area. Using an insulin and plastic syringe (needle: 30-gauge, 8 mm length), 1-2 gram /0.1-0.2 ml of Omega-3 (PUFAs) will be injected into the gingiva at approximately the epithelial connective tissue interface until the tissue blanche, 2-3 mm apart. The insulin syringe, bevel facing upward, will be inserted into the corresponding gingival tissues. For four weeks, this dosage of omega-3 (PUFAs) will be administered once a week. Furthermore, patients will take 2 capsules. Each capsule contains 1 gram of Omega3(PUFAs) as an additional food supplement (up to 3 gram daily for the period of injection except the day of injection. the patients will receive a packet containing required number of capsules have to be taken every week.
PROCEDURE	surgical treatment	Patients with gingival hyperpigmentation of oral mucosa. For the scalpel technique, following the administration of a local anesthetic solution, a partial split thickness flap was raised with the help of blade no. 15 with the Bard Parker handle to scrape the epithelium in maxillary anterior area from canine to canine in the other side; will be surgical removal of pigmentation using the scalpel in 45 degrees to remove the superficial layer. Bleeding Will be controlled using a pressure pack with sterile gauze. Care was taken that excessive tissue was not removed thereby avoiding any bone exposure. This will be followed by careful examination of the exposed connective tissue surface, and the wound will be irrigated with saline. Bleeding will be controlled using a pressure pack, and once hemostasis is achieved, the site will be covered by a periodontal dressing for a period of one week. patients will be advised to stop eating hard, acidic, spicy, and colored foods before surgery. All patie

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-08-07
• Completion: 2025-08-28
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study