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| ID | Type | Description | Link |
|---|---|---|---|
| self funded | Other Identifier | no organization |
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This new study compares the effectiveness of scalpel surgery and omega-3 poly unsaturated fatty acid (PUF) injections in treating gingival hyperpigmentation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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- |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
.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.
Exclusion Criteria:
The patient with the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Assistant Professor of Oral Medicine and Periodontology | Suez Canal University | Principal Investigator |
| Lecturer of Oral medicine and Periodontology | Suez Canal University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University | Ismailia | 41542 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42046081 | Derived | Hussien RE, Mahmoud RSE, Morsy SM. Effectiveness of omega-3 poly unsaturated fatty acids on the treatment of gingival hyperpigmentation: a randomized controlled clinical trial. BMC Oral Health. 2026 Apr 28;26(1):787. doi: 10.1186/s12903-026-08354-y. |
| ID | Type | URL | Comment |
|---|---|---|---|
| Free PMC article. | View IPD |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017496 | Hypopigmentation |
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| ID | Term |
|---|---|
| D005231 | Fatty Acids, Unsaturated |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| 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 |
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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 |
| PMC article. | View IPD |
| Free PMC article. | View IPD |