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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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04495205
Enrollment
24
Registered
2020-07-31
Start date
2020-01-01
Completion date
2021-03-31
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Pigmentation

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.

Interventions

BIOLOGICALPRF under non-eugenol containing periodontal pack

Platelet Rich Fibrin under non-eugenol containing periodontal pack

OTHERNon-eugenol containing periodontal pack

Non-eugenol containing periodontal pack after gingival depigmentation

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the statistician are masked

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain1st day post-operativeVisual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)

Secondary

MeasureTime frameDescription
Re-epithelization5th day post-operativeToulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
Wound healing3rd day post-operativeHealing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Re-pigmentation6 months post-operativeRe-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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026