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

NCT07067515 | Active Not Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: Suez Canal Universityself funded
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperpigmentation; Gingival Hyperpigmentaion

Keywords

depigmentation; omega 3; poly unsaturated fatty acids; racial pigmentation

Outcome Measures

Primary Outcomes (1)

• Change in gingival pigmentation

  decrease melanin color of the gingiva and transform into regular pink color either by surgical; or non-surgical technique measured by The Dummett oral pigmentation (DOPI) (Dummett, 1945) for the intensity of oral pigmentation The scoring criteria as 0=Gingiva in pink color,1=Mild light brown gingival color,2=Medium gingival color or mixed (brown \&pink) gingival color and 3=Deep brown /blue-black gingival color

  measured at baseline, 1 month, 3 month and 6 months postoperative

Secondary Outcomes (4)

• post operative pain

  After the procedures, a day of procedures and a week of procedures

• changes in gingival pigmentation distribution

  base line ,1month,3 months and 6 months

• Gingival bleeding

  At the time of procedures

• wound healing

  After a day of procedures and after a 7-10 day of procedures

Study Arms (2)

surgical treatment

ACTIVE COMPARATOR

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-

Procedure: surgical treatment

non surgical with PUFA injection

EXPERIMENTAL

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.

Combination Product: non surgical with PUFA injection

Interventions

non surgical with PUFA injection COMBINATION_PRODUCT

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.

non surgical with PUFA injection

surgical treatment PROCEDURE

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

surgical treatment

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients complained of mild to moderate gingival hyperpigmentation in the anterior area of maxilla.
• Systemically healthy subjects with Dummett and Bolden index score 1,2 and 3 having well-maintained oral hygiene, with aesthetic concern and willing to undergo minor surgical procedures.
• Adequate oral hygiene conditions.
• Age from 21-50 years old.
• All patients will be physically healthy with no medical history of any systemic disease that will contraindicate the use of omega-3 (PUFAs) or may complicate the healing process.
• Co-operative motivated patients

You may not qualify if:

• The patient with the following criteria will be excluded from the study:
• patients complaining of sever gingival hyperpigmentation in the anterior area of maxilla.
• Smokers.
• Pregnant, lactating (breast feeding) women's.
• Patient with allergy to anesthesia
• Patients undergoing chemotherapy or radiotherapy

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41542, Egypt

Location

Related Links

• Balcos, M.C., Kim, S.Y., Jeong, H.S., Yun, H.Y., Baek, K.J., Kwon, N.S., Park, K.C. and Kim, D.S., 2014. Docosahexaenoic acid inhibits melanin synthesis in murine melanoma cells in vitro through increasing tyrosinase degradation. Acta Pharmacologica Sini

MeSH Terms

Conditions

Hyperpigmentation; Vitiligo

Interventions

Fatty Acids, Unsaturated; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Hypopigmentation

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Study Officials

• Assistant Professor of Oral Medicine and Periodontology

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Lecturer of Oral medicine and Periodontology

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 16, 2025
• Study Start: January 3, 2024
• Primary Completion: August 7, 2025
• Study Completion: August 28, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)