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

NCT ID: NCT07067515

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2025-08-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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-

Group Type: ACTIVE_COMPARATOR

surgical treatment

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

non surgical with PUFA injection

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assistant Professor of Oral Medicine and Periodontology

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Lecturer of Oral medicine and Periodontology

Role: STUDY_DIRECTOR

Suez Canal University

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Study Documents

Document Type: Free PMC article.

View Document

Document Type: PMC article.

View Document

Document Type: Free PMC article.

View Document

Related Links

https://www.bing.com/ck/a?!&&p=b33d114f981f97fc13862467968ac502c5149a84fe73c582cc521217a761ec04JmltdHM9MTc0NDU4ODgwMA&ptn=3&ver=2&hsh=4&fclid=0ecbbb60-da4a-6df3-1656-aa91db366c5e&psq=pubmed+search&u=a1aHR0cHM6Ly9wdWJtZWQubmNiaS5ubG0ubmloLmdvdi8&ntb=1

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

Other Identifiers

self funded

Identifier Type: OTHER

Identifier Source: secondary_id

Suez Canal University

Identifier Type: -

Identifier Source: org_study_id