Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation

Cairo University (CU)

Status and phase: Enrolling; Phase 4

Conditions: Gingival Pigmentation

Treatments: Drug: COE-PAK™; Drug: NBF GINGIVAL GEL®; Drug: blue®m Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05837416

16223

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Oxygen Releasing Oral Gel (blue®m) with Coe-Pak dressing

Experimental group

Description:

topical application of Oxygen Releasing Oral Gel (blue®m) on the surgical site followed by Coe-Pak immediately after gingival depigmentation surgery, then 1 week postoperatively

Treatment:

Drug: blue®m Gel

Nano-emulsion complex propolis and vitamin C (NBF GINGIVAL GEL®) with Coe-Pak dressing

Experimental group

Description:

topical application of Nano-emulsion complex propolis and vitamin C (NBF GINGIVAL GEL®) on surgical site followed by Coe-Pak immediately after surgery, then 1 week postoperatively

Treatment:

Drug: NBF GINGIVAL GEL®

COE-PAK periodontal dressing only

Active Comparator group

Description:

Periodontal dressing (COE-PAK) will be applied on surgical site only .

Treatment:

Drug: COE-PAK™