Clinical trial NCT04495205: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gingival Pigmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post-operative pain
timeFrame: 1st day post-operative
measure: Post-operative pain
timeFrame: 3rd day post-operative
measure: Post-operative pain
timeFrame: 5th day post-operative
Secondary outcomes:
measure: Re-epithelization
timeFrame: 5th day post-operative
measure: Wound healing
timeFrame: 3rd day post-operative
measure: Wound healing
timeFrame: 5th day post-operative
measure: Re-pigmentation
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Faculty of Dentistry
Study officials:
References:
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.