- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495205
Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
Clinical Comparison of the Effect of Non-eugenol Containing Periodontal Pack With and Without Platelet Rich Fibrin on Post-operative Pain and Wound Healing After Surgical Gingival Depigmentation: A Randomized Clinical Trial
In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived pigment formed by cells called melaonocytes
Dental cosmetic procedures including gingival depigmentation among the young generation are vastly becoming popular due to the public advertising of what the "ideal smile" should be. This means that brown/ pigmented gingiva is not esthetically accepted by modern standards. Numerous techniques for depigmentation were developed including surgical abrasion, lasers, chemicals and thermal techniques.
The use of post-operative non-eugenol containing periodontal packs acts as a mechanical barrier for coverage of the denuded area which prevents bleeding and promotes healing by preventing trauma to the area.
Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that promote healing and tissue regeneration. Its use in the medical and dental fields is expanding during the recent year.
Study Overview
Status
Conditions
Detailed Description
Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques require the use of post-operative periodontal pack. The periodontal pack protects the surgical site from surface trauma, stops the post-operative bleeding and infection as well as stabilizing the blood clot and accelerate healing.
However, a review article discussed the adverse effects of periodontal pack as it may cause plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of the tissues. In the article, there were clinical trials that advocated that wound healing could occur without the need of periodontal pack if the surgical wound was kept clean alone indicating that the pack does not affect the wound healing.
This gave rise to idea to use a material that has been proven to accelerate wound healing and decrease the patient discomfort to be placed under the periodontal pack which would be used only as a protective barrier.
Several studies tested platelet rich concentrates as adjunctive methods under periodontal packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They found that there was a clinical, histological and statistical difference between the groups favoring the platelet concentrate groups.
Using PRF which is a second generation platelet concentrate first developed by Choukroun et al in 2001 used as a membrane could provide accelerated wound healing properties which would accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used which will provide a mechanical barrier to protect the wound from any stimulus.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt
- Recruiting
- Cairo University faculty of dentistry
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Contact:
- Mona S Darhous, Professor
- Phone Number: 00201223155955
- Email: mona.darhous@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages18-40 years old
- Systemically healthy
- Mild to moderate gingival pigmentations
- Gingival and plaque index <1
- Good oral hygiene
- Thick gingival biotypes
- Keratinized gingiva >2mm
Exclusion Criteria:
- Smokers
- Taking any medications that could affect healing
- Pervious depigmentation procedures
- Pregnant or lactating females
- Pervious periodontal surgery within the last 6 months before the start of the trial
- Endodontically treated teeth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-eugenol containing periodontal packs with PRF
Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation
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Platelet Rich Fibrin under non-eugenol containing periodontal pack
Other Names:
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Placebo Comparator: Non-eugenol containing periodontal packs
Non-eugenol containing periodontal packs after gingival de-pigmentation
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Non-eugenol containing periodontal pack after gingival depigmentation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain
Time Frame: 1st day post-operative
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Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
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1st day post-operative
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Post-operative pain
Time Frame: 3rd day post-operative
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Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
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3rd day post-operative
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Post-operative pain
Time Frame: 5th day post-operative
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Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
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5th day post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-epithelization
Time Frame: 5th day post-operative
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Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
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5th day post-operative
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Wound healing
Time Frame: 3rd day post-operative
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Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
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3rd day post-operative
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Wound healing
Time Frame: 5th day post-operative
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Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
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5th day post-operative
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Re-pigmentation
Time Frame: 6 months post-operative
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Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached)
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6 months post-operative
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHReda
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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