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

NCT ID: NCT05837416

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-05-31

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.

Conditions

Gingival Pigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

blue®m Gel

Intervention Type: DRUG

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

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

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

Group Type: EXPERIMENTAL

NBF GINGIVAL GEL®

Intervention Type: DRUG

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

COE-PAK periodontal dressing only

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

Group Type: ACTIVE_COMPARATOR

COE-PAK™

Intervention Type: DRUG

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

Interventions

blue®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

Intervention Type: DRUG

NBF 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

Intervention Type: DRUG

COE-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

Intervention Type: DRUG

Other Intervention Names

Oxygen Releasing Oral Gel; nano bio fusion gingival gel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadeer Metwally Shafik Metwally

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Darhous, PHD

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hadeer M. Shafik Metwally, Bachelor

Role: CONTACT

hader.metwally@dentistry.cu.edu.eg

01151877398 ext. +20

Other Identifiers

16223

Identifier Type: -

Identifier Source: org_study_id