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

Comparative Study of the Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation. (A Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Recruiting
• Conditions: Gingival Pigmentation
• Intervention / Treatment: Drug: blue®m Gel; Drug: NBF GINGIVAL GEL®; Drug: COE-PAK™

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hadeer M. Shafik Metwally, Bachelor; Phone Number: +20 01151877398; Email: hader.metwally@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Cairo University
    • Principal Investigator: Hadeer M. Shafik Metwally, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Oxygen Releasing Oral Gel
Experimental: 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	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; Other Names: nano bio fusion gingival gel
Active Comparator: COE-PAK periodontal dressing only; Periodontal dressing (COE-PAK) will be applied on surgical site only .	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient Satisfaction	Questionnaire (yes/no)	30 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mona Darhous, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Oxidant Gel; Anti-oxidant Gel; Gingival depigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation
• Other Study ID Numbers: 16223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No