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NCT Number: NCT07067515

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hyperpigmentation Gingival Hyperpigmentaion Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Suez Canal University

Ismailia, 41542, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Change in gingival pigmentation

    Time frame: measured at baseline, 1 month, 3 month and 6 months postoperative

    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

Secondary outcomes

  1. post operative pain

    Time frame: After the procedures, a day of procedures and a week of procedures

    measure the post operative pain at 10-point Visual Analogue Scale (VAS). from '0=No pain' to increasing pain intensity at '10=Worst pain

  2. changes in gingival pigmentation distribution

    Time frame: base line ,1month,3 months and 6 months

    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

  3. Gingival bleeding

    Time frame: At the time of procedures

    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

  4. wound healing

    Time frame: After a day of procedures and after a 7-10 day of procedures

    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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Acronym: Omega-3

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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