Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype

Blood Clot Clinical Trial

Official title:

New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274674
• Other study ID #: boz002
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures

Description:

Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Never smokers

• Had no history of systemic disease

• Aged =18 years old

Exclusion Criteria:

• Patients with a history of diabetes mellitus or systemic disease

• Patients who were under any medication that was known to influence periodontal tissues

• Patients with hormonal changes such as pregnancy or lactation

• Toothless individuals

• Patients who were clotting disorders

Related Conditions & MeSH terms

• Blood Clot
• Condition
• Gingiva Disorder
• Gingiva; Injury
• Periodontoclasia
• Thrombosis

Intervention

Other:
• I-PRF
Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.

Locations

Country	Name	City	State
Turkey	Zeliha Betül ÖZSAGIR	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival thickness (mm)	Change in clinical measures of gingival thickness	2 months
Secondary	Plaque Index (PI)	Change in clinical measures of gingival parameters	2 months
Secondary	Gingival Index (GI)	Change in clinical measures of gingival parameters	2 months
Secondary	Bleeding on probing (BOP)	Change in clinical measures of gingival parameters	2 months
Secondary	Clinical attachment level (CAL)	Change in clinical measures of gingival parameters	2 months
Secondary	Probing pocket depth (PD)	Change in clinical measures of gingival parameters	2 months