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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperpigmentation; Gingival Hyperpigmentaion
• Intervention / Treatment: Procedure: surgical treatment; Combination product: non surgical with PUFA injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41542
    • Suez Canal University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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
Active Comparator: 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-	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
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	measure the post operative pain at 10-point Visual Analogue Scale (VAS). from '0=No pain' to increasing pain intensity at '10=Worst pain	After the procedures, a day of procedures and a week of procedures
changes in gingival pigmentation distribution	measure the changes in gingival pigmentation distribution by Hedin melanin index (Hedin, 1977) scoring criteria 0=No pigmentation,1=One or two solitary units,2=More than three units of pigmentation in the papillary gingiva without formation of a continuous ribbon,3=One or more short continuous ribbons of pigmentation and 4=One continuous ribbon including the entire area between the canines an interdental papilla with half of the marginal gingiva on either side	base line ,1month,3 months and 6 months
Gingival bleeding	severity of gingival bleeding as assessed by the scoring criteria as follows: 0=No bleeding, 1=Isolated bleeding, 2=Mild bleeding, 3=Moderate or severe bleeding	At the time of procedures
wound healing	measure the post-operative wound healing are estimated and scored as follow :0= presence of necrotic gingival tissue ,1=presence of the ulcer in the gingiva, 2=incomplete gingival epithelization ,3=complete gingival epithelization	After a day of procedures and after a 7-10 day of procedures

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Assistant Professor of Oral Medicine and Periodontology, Suez Canal University; Study Director: Lecturer of Oral medicine and Periodontology, Suez Canal University

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): August 7, 2025
• Study Completion (Estimated): August 28, 2025

Study Registration Dates

• First Submitted: June 2, 2025
• First Submitted That Met QC Criteria: July 6, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: omega 3; depigmentation; poly unsaturated fatty acids; racial pigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: Suez Canal University (ethtical committee of suez canal university); self funded (Other Identifier: Cairo University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Free PMC article.
2. PMC article.
3. Free PMC article.

Drug and device information, study documents

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