Gingival PigmentationPhase 4NCT05837416
Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation
A Phase 4 study testing blue®m Gel, NBF GINGIVAL GEL® and COE-PAK™ in people with Gingival Pigmentation, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- blue®m Gel, NBF GINGIVAL GEL® and COE-PAK™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2023to May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11562
Hadeer M. Shafik Metwally, Bachelor
About this study
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)
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
Read the 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
- Being tested
- blue®m Gel, NBF GINGIVAL GEL®, COE-PAK™
- Keywords
- Oxidant Gel, Anti-oxidant Gel, Gingival depigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blue®m GelDrug
Also called Oxygen Releasing Oral 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®Drug
Also called nano bio fusion 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™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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: NBF GINGIVAL GEL® |
| COE-PAK periodontal dressing only | Active comparator | Periodontal dressing (COE-PAK) will be applied on surgical site only . Receives: Drug: COE-PAK™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in healing from baseline up to 4 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 14 days
Patient Satisfaction
Questionnaire (yes/no)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start28 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Metwally Shafik Metwally, Cairo University
- Investigators
- Mona Darhous, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837416
- Sponsor's protocol ID
- 16223
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05837416
- Acronym / sponsor ID
- 16223
- Conditions
- Gingival Pigmentation
- Keywords
- Oxidant Gel, Anti-oxidant Gel, Gingival depigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxygen Releasing Oral Gel (blue®m) with Coe-Pak dressing | Experimental | Drug: blue®m Geltopical 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 |
| Nano-emulsion complex propolis and vitamin C (NBF GINGIVAL GEL®) with Coe-Pak dressing | Experimental | Drug: NBF GINGIVAL GEL®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 |
| COE-PAK periodontal dressing only | Active comparator | Drug: COE-PAK™Periodontal dressing (COE-PAK) will be applied on surgical site only . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blue®m GelAlso: Oxygen Releasing Oral GelOxygen 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 | Drug | Oxygen Releasing Oral Gel (blue®m) with Coe-Pak dressing |
| NBF GINGIVAL GEL®Also: nano bio fusion gingival gelAnti-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 | Drug | Nano-emulsion complex propolis and vitamin C (NBF GINGIVAL GEL®) with Coe-Pak dressing |
| 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 | Drug | COE-PAK periodontal dressing only |
Primary outcome
wound healing
Time frame: Change in healing from baseline up to 4 weeks
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.
3 secondary outcomes
Post-operative Pain Assessment
Time frame: 7 days
Post-operative Pain Assessment
Time frame: 14 days
Patient Satisfaction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Gingival Pigmentation
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Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
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Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation
Gingival Pigmentation, Gingiival Hyperpigmentation
Not yet recruiting
Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
Gingival Pigmentation
Recruiting
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation
Depigmentation Treatment, Depigmentation
RecruitingPhase 2
Gingival Hyperpigmentation Treatment
Gingival Pigmentation, Depigmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Darhous, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing blue®m Gel, NBF GINGIVAL GEL® and COE-PAK™ in people with Gingival Pigmentation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeer M. Shafik Metwally, Bachelor (01151877398 ext. +20, hader.metwally@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: Change in healing from baseline up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.