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

Gingival Pigmentation Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837416
• Other study ID #: 16223
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: Hadeer M. Shafik Metwally, Bachelor
• Phone: 01151877398
• Email: hader.metwally[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Pigmentation
• Hypopigmentation

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	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.	Change in healing from baseline up to 4 weeks
Secondary	Post-operative Pain Assessment	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	7 days
Secondary	Post-operative Pain Assessment	pain score will be measured at 2nd week. Visual Analogue Scale (VAS) will be used to evaluate pain with score starting from 0 (minimal pain ) to 10 ( maximum pain) . Questionnaire	14 days
Secondary	Patient Satisfaction	Questionnaire (yes/no)	30 days