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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05837416
Other study ID # 16223
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT05453890 - The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population.
Completed NCT06167148 - Gingival Depigmentation Using Diode Laser 940nm Versus 980nm N/A
Not yet recruiting NCT05930392 - Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation N/A
Not yet recruiting NCT05930366 - Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation N/A
Recruiting NCT04495205 - Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation Early Phase 1
Completed NCT05283668 - Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation Phase 4
Not yet recruiting NCT03791957 - The Association of Blood Haemoglobin and Colour of Gums
Recruiting NCT06312605 - The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial) Phase 4
Not yet recruiting NCT05786885 - Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation N/A