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

NCT05837416 | Unknown Phase 4 DMC

• 1 other identifier: 16223
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Pigmentation

Keywords

Oxidant Gel; Anti-oxidant Gel; Gingival depigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-operative Pain Assessment

  7 days

• Post-operative Pain Assessment

  14 days

• Patient Satisfaction

  30 days

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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®

COE-PAK periodontal dressing only

ACTIVE COMPARATOR

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

Drug: COE-PAK™

Interventions

blue®m Gel 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

Also known as: Oxygen Releasing Oral Gel

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

NBF GINGIVAL GEL® 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

Also known as: nano bio fusion gingival gel

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

COE-PAK™ 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

COE-PAK periodontal dressing only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Coe-Pak

Study Officials

• Mona Darhous, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hadeer M. Shafik Metwally, Bachelor

CONTACT

01151877398; hader.metwally@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 1, 2023
• Study Start: February 28, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)