Gingival Pigmentation
Conditions
Keywords
Oxidant Gel, Anti-oxidant Gel, Gingival depigmentation
Brief summary
To evaluate effect of Oxidant (Oxygen Releasing Oral Gel) with Coe-Pak versus Anti-oxidant (Nano-emulsion complex propolis and vitamin C gel) with Coe-Pak on wound healing, pain, patient satisfaction after gingival depigmentation
Detailed description
Gingival depigmentation is considered a periodontal plastic surgery, in which gingival hyperpigmentation is eliminated. The scalpel surgical method is one of the most cost-effective methods, easiest and does not need broad equipment. However, scalpel surgery leads to bleeding during and after surgery, and the surgical area has to be covered with periodontal dressing for 7-10 days. Periodontal dressings are used around the necks of the teeth and surrounding tissue to cover the wound. Non-eugenol dressings are now the most commonly used periodontal dressings include Coe-Pak, Cross Pack, Peripac, Septopack, PerioCare, Perio Putty and Periogenix. Anti-oxidant gel (Nano-emulsion complex propolis and vitamin C - NBF GINGIVAL GEL®) is a high efficiency nano bio fusion gel containing propolis, nano vitamin C, E and herb extract. Anti-oxidant power of nano Vitamin C (NBF GINGIVAL GEL®) is ten times more effective in hundred times smaller amounts, than Vitamin C by itself. Vitamin C collaboratives with Vitamin E and preserves cell membranes integrity. Propolis has antioxidant effect due to its radical scavenging ability, which was more efficient than antioxidant effect of vitamin C. it also enhances synthesis of collagen due to the presence of iron and zinc elements. it has proven to increase healing of epithelial tissues. The presence of oxygen in Oxygen Releasing Oral Gel (blue®m gel) enhances cellular metabolism, collagen synthesis, antibacterial activity, angiogenesis, revascularization, and the release of growth factors, it also helps keratinized tissue formation and has antimicrobial effects.
Interventions
DRUGblue®m Gel
Oxygen will be released after application Oxygen Releasing Oral Gel (blue®m gel) creating a partially high oxygen pressure (pO2), which aids in restoring the micro-environment for a healthy oral cavity
DRUGNBF GINGIVAL GEL®
Anti-oxidant gel (Nano-emulsion complex propolis and vitamin C - NBF GINGIVAL GEL®) is a nano bio fusion gel containing propolis, nano vitamin C, E and herb extract
DRUGCOE-PAK™
It is non eugenol periodontal dressing. It is supplied in two tubes, the contents of which are mixed immediately before use. One tube contains zinc oxide, oil, a gum, and lorothidol. The other tube contains liquid coconut fatty acids thickened with colophony resin and chlorothymol
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor and biostatistician will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years with anterior maxillary or mandibular physiologic gingival pigmentation * Systemically healthy patients * Good oral hygiene, Plaque index less than 15%. * Cooperative patients able and accept to come for follow up appointments
Exclusion criteria
* Any interim intervention that may have affected any of the outcomes of interest. * Pregnant and lactating females. * Smokers * Patients reporting systemic conditions that may cause hyperpigmentation (eg.Addison's disease) or on medications (eg. Corticosteroids) * Patients reporting systemic conditions that may compromise healing (eg. Diabetes) * Patients with poor oral hygiene. * Any known allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing | Change in healing from baseline up to 4 weeks | Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing).Postoperatively clinical photographs will be taken. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Assessment | 7 days | pain score will be measured at 1st week . Visual Analogue Scale (VAS) will be used to evaluate pain with score starting from 0 (minimal pain ) to 10 ( maximum pain). Questionnaire |
| Patient Satisfaction | 30 days | Questionnaire (yes/no) |
Countries
Egypt
Contacts
Primary ContactHadeer M. Shafik Metwally, Bachelor
Outcome results
None listed