Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

Periapical Periodontitis Clinical Trial

Official title:

Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528240
• Other study ID #: S58015 / B322201525314/ I / U
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Provision of Informed Consent

• Patients in need of an EMS

• EMS is the only option to cure the periapical lesion

Exclusion Criteria:

• Unlikely to be able to comply with the study procedures, as judged by the investigator

• Orthograde endodontic (re)treatment is indicated

• Known or suspected current malignancy

• History of chemotherapy within 5 years prior to study

• History of radiation in the head and neck region

• History of other metabolic bone diseases

• History of bleeding disorders

• HIV disease

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• EMS

Device:
• + occlusive membrane

• conebeam CT

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of periapical bone healing in time	Assessed with conebeam CT and periapical radiography	4 years
Other	Timeframe in which the cortical bone plate closes	Assessed with echography	1 year
Other	Bone or scar tissue healing	Assessed with conebeam CT	4 years
Other	Dentinal defects	Assessed with a LED light source	1 day
Other	Type of periapical tissue	Assessed by biopsy	7 days
Primary	Patient related outcomes	Assessed with a Visual Analog Scale	7 days
Secondary	Patient related outcomes	Assessed with a questionnaire	7 days