Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
Primary Purpose
Gingival Pigmentation
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
PRF under non-eugenol containing periodontal pack
Non-eugenol containing periodontal pack
Sponsored by
About this trial
This is an interventional supportive care trial for Gingival Pigmentation
Eligibility Criteria
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
Sites / Locations
- Cairo University Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Non-eugenol containing periodontal packs with PRF
Non-eugenol containing periodontal packs
Arm Description
Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation
Non-eugenol containing periodontal packs after gingival de-pigmentation
Outcomes
Primary Outcome Measures
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Secondary Outcome Measures
Re-epithelization
Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
Wound healing
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Wound healing
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Re-pigmentation
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04495205
Brief Title
Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Pigmentation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the statistician are masked
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-eugenol containing periodontal packs with PRF
Arm Type
Experimental
Arm Description
Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation
Arm Title
Non-eugenol containing periodontal packs
Arm Type
Placebo Comparator
Arm Description
Non-eugenol containing periodontal packs after gingival de-pigmentation
Intervention Type
Biological
Intervention Name(s)
PRF under non-eugenol containing periodontal pack
Other Intervention Name(s)
Platelet Rich Fibrin
Intervention Description
Platelet Rich Fibrin under non-eugenol containing periodontal pack
Intervention Type
Other
Intervention Name(s)
Non-eugenol containing periodontal pack
Intervention Description
Non-eugenol containing periodontal pack after gingival depigmentation
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Time Frame
1st day post-operative
Title
Post-operative pain
Description
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Time Frame
3rd day post-operative
Title
Post-operative pain
Description
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Time Frame
5th day post-operative
Secondary Outcome Measure Information:
Title
Re-epithelization
Description
Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
Time Frame
5th day post-operative
Title
Wound healing
Description
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Time Frame
3rd day post-operative
Title
Wound healing
Description
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Time Frame
5th day post-operative
Title
Re-pigmentation
Description
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)
Time Frame
6 months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cairo University Faculty of Dentistry
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona S Darhous, Professor
Phone
00201223155955
Email
mona.darhous@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31367132
Citation
Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.
Results Reference
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Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
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