Gingival Hyperpigmentaion, Hyperpigmentation
Conditions
Keywords
depigmentation, omega 3, poly unsaturated fatty acids, racial pigmentation
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.
Interventions
COMBINATION_PRODUCTnon 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.
PROCEDUREsurgical 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
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival pigmentation | 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
| Measure | Time frame | Description |
|---|---|---|
| post operative pain | 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 |
| changes in gingival pigmentation distribution | 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 |
| Gingival bleeding | 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 |
| wound healing | 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 |
Countries
Egypt
Outcome results
None listed