Clinical trial NCT05837416: Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation
Official title: Comparative Study of the Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation. (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gingival Pigmentation
Keywords: Oxidant Gel
Anti-oxidant Gel
Gingival depigmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound healing
timeFrame: Change in healing from baseline up to 4 weeks
Secondary outcomes:
measure: Post-operative Pain Assessment
timeFrame: 7 days
measure: Post-operative Pain Assessment
timeFrame: 14 days
measure: Patient Satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mona Darhous, PHD
role: STUDY_DIRECTOR
References: