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Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Healing After Periradicular Surgery

Primary Purpose

Apical Periodontitis, Periapical Lesion

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Retrograde Filling Group
Retrograde Filling+L-PRF Group
(Orthograde Filling Group / OG Group).
(Orthograde Filling+L-PRF Group
Sponsored by
Seyda Ersahan, DDS, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

60 volunteer patients over the age of 18 who applied to Istanbul Medipol University Faculty of Dentistry, Department of Endodontics and were diagnosed with refractory chronic apical periodontitis due to a periapical lesion of endodontic origin that did not respond to root canal treatment, will be included in the study, regardless of gender. Periapical surgery will be applied in all patients following the endodontic retreatment. Inclusion Criteria: Being over 18 years old. systemic status is ASA I. No history of allergy to local anesthetics and drugs to be used. D. Absence of a systemic disease or drug use that may adversely affect wound healing and contraindicate oral surgical procedures (radiotherapy, chemotherapy, corticosteroid use, antiplatelet or anticoagulant drug use, connective tissue diseases, vascular diseases, blood dyscrasia, liver diseases, uncontrolled diabetes, etc.). to. Not smoking more than 10 cigarettes per day. f. Having a single rooted tooth of endodontic origin, with a periradicular lesion larger than 5 mm and smaller than 12 mm in diameter detected on periapical radiograph (chronic apical periodontitis), re-canal treatment planned and thought to be unsuccessful with re-canal treatment alone. Exclusion Criteria: Having ASA II-III-IV. Having a history of allergy to local anesthetics and drugs to be used. Presence of a systemic disease or drug use that may adversely affect postoperative wound healing and periodontal health. D. Being pregnant or lactating. to. Not using antiplatelet or anticoagulant drugs and having blood dyscrasias f. Smoking more than 10 cigarettes per day. g. Vertical root fracture, perforation in the furcation region, endo-perio lesion and more than 5 mm periodontal bone loss in the involved tooth.

Sites / Locations

  • Istanbul Medipol University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1. group: Retrograde Filling Group / RG Group

2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group

3. Group: Orthograde Filling Group / OG Group

4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF Group

Arm Description

Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect

Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect.

Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect.

Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect.

Outcomes

Primary Outcome Measures

Apical lesion healing
Periapical index score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. The PAI is a basic radiographic method of interpretation consisting of a scale from 1 to 5. It was first described by Ørstavik et al in 1986 (14). For each subject, the periapical tissue was assessed radiographically using the PAI as follows: PAI 1: normal periapical structure PAI 2: small changes in the bone structure not pathognomonic of apical periodontitis PAI 3: changes in the bone structure with mineral loss characteristic of apical periodontitis PAI 4: well-defined apical radiolucency characteristic of apical periodontitis PAI 5: severe periodontitis with exacerbating features and bone expansion

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
August 26, 2023
Sponsor
Seyda Ersahan, DDS, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05847647
Brief Title
Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Healing After Periradicular Surgery
Official Title
Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Clinical and Radiographic Healing After Periradicular Surgery: Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
October 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seyda Ersahan, DDS, PhD

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
The aim of this study is to evaluate the effect of two different periapical surgery methods ("curettage+apical resection" and "curettage") on the bone regeneration and clinical healing without applying any material or with applying leukocyte and platelet rich fibrin (L-PRF) to the periradicular intraosseous defect in the treatment of the teeth with large periapical lesions by following the patients for 12 months.
Detailed Description
Materials and Methods: Apical periodontitis is a local response of the bone around the root tip of the tooth to necrosis of the pulp tissue. In the treatment of apical periodontitis, it is primarily aimed to remove the pathogenic microorganisms responsible for the infection with root canal treatment. The success of root canal treatment depends on the complete repair and regeneration of periapical tissues, and most of the periapical lesions heal satisfactorily after root canal treatment, but there are cases where infection and persistent symptoms persist despite root canal treatment. In these cases, periapical surgery with endodontic retreatment is required to eliminate pathological tissues, eliminate the source of irritation and support the healing process. For this purpose, 2 different periapical surgical methods are performed. In the first method, which is a more radical technique, the tip of the root of the related tooth responsible for apical periodontitis is resected (apicectomy) after curettage of the bone defect area. In the second method, in which the tooth tissue is preserved with a more conservative approach, only the defect area is curetted without root tip resection. Different results regarding the clinical success of these two methods have been reported in the literature. In many studies, apicectomy is accepted as principal part of periapical surgical procedures and a prerequisite for the success of treatment but, roots that have already weakened and thinned due to periodontitis become more prone to fracture. In addition, especially in cases where the ratio between crown and root length is impaired, the stability of the restoration is adversely affected and the stability of the tooth in the socket may become questionable in the long term. In the literature, there are only a few case reports and a clinical study evaluating the clinical success of periapical surgery performed with periapical curettage without apicectomy following endodontic retreatment. In recent years, many studies have been carried out to increase the success of apical surgery by accelerating and increasing the formation of new bone in the defect area with regenerative applications. Leukocyte and platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate that forms an organized fibrin network in which platelets and leukocytes are trapped. In the few studies in the literature regarding the use of L-PRF alone without combining with a graft, in periapical surgery, apical surgery has been performed with root tip resection. In the literature, there is only one case series evaluating the effect of L-PRF application on periapical intraosseous defect after apical curettage without apicectomy on clinical and radiological healing. In the treatment of apical periodontitis cases whith persistant symptoms and infection despite root canal treatment; more successful long-term results are aimed to be achieved by curettage of the periapical lesion and placement of L-PRF in the intraosseous defect after endodontic retreatment providing acceleration of apical bone regeneration, reducing clinical symptoms, and preserving the tooth root with a more conservative approach. 60 volunteer patients over the age of 18 who applied to Istanbul Medipol University Faculty of Dentistry, Department of Endodontics and were diagnosed with refractory chronic apical periodontitis due to a periapical lesion of endodontic origin that did not respond to root canal treatment, will be included in the study, regardless of gender. Periapical surgery will be applied in all patients following the endodontic retreatment. Patients will be randomly divided into 4 groups of 15 patients in each group: Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect (Retrograde Filling Group / RG Group). Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect (Retrograde Filling+L-PRF Group / RG+L-PRF Group). Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect (Orthograde Filling Group / OG Group). Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect (Orthograde Filling+L-PRF Group / OG+L-PRF Group). All surgical operations will be performed by the same surgeon, and all endodontic treatments will be performed by the same endodontist. Patients will be called for control for clinical and radiographic evaluation at 1. week and 1., 3., 6., 9., and 12. months. The PAI (Periapical index) score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. Patients will be given forms including a 10-unit Numeric Rating Scale (NRS), and they will be asked to mark the pain they feel every day for 1 week postoperatively and to record the number of painkillers they use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Periapical Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. group: Retrograde Filling Group / RG Group
Arm Type
Experimental
Arm Description
Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect
Arm Title
2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group
Arm Type
Experimental
Arm Description
Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect.
Arm Title
3. Group: Orthograde Filling Group / OG Group
Arm Type
Experimental
Arm Description
Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect.
Arm Title
4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF Group
Arm Type
Experimental
Arm Description
Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect.
Intervention Type
Other
Intervention Name(s)
Retrograde Filling Group
Intervention Description
Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect.
Intervention Type
Other
Intervention Name(s)
Retrograde Filling+L-PRF Group
Intervention Description
2. Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect (
Intervention Type
Other
Intervention Name(s)
(Orthograde Filling Group / OG Group).
Intervention Description
3. Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect
Intervention Type
Other
Intervention Name(s)
(Orthograde Filling+L-PRF Group
Intervention Description
4. Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect
Primary Outcome Measure Information:
Title
Apical lesion healing
Description
Periapical index score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. The PAI is a basic radiographic method of interpretation consisting of a scale from 1 to 5. It was first described by Ørstavik et al in 1986 (14). For each subject, the periapical tissue was assessed radiographically using the PAI as follows: PAI 1: normal periapical structure PAI 2: small changes in the bone structure not pathognomonic of apical periodontitis PAI 3: changes in the bone structure with mineral loss characteristic of apical periodontitis PAI 4: well-defined apical radiolucency characteristic of apical periodontitis PAI 5: severe periodontitis with exacerbating features and bone expansion
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
60 volunteer patients over the age of 18 who applied to Istanbul Medipol University Faculty of Dentistry, Department of Endodontics and were diagnosed with refractory chronic apical periodontitis due to a periapical lesion of endodontic origin that did not respond to root canal treatment, will be included in the study, regardless of gender. Periapical surgery will be applied in all patients following the endodontic retreatment. Inclusion Criteria: Being over 18 years old. systemic status is ASA I. No history of allergy to local anesthetics and drugs to be used. D. Absence of a systemic disease or drug use that may adversely affect wound healing and contraindicate oral surgical procedures (radiotherapy, chemotherapy, corticosteroid use, antiplatelet or anticoagulant drug use, connective tissue diseases, vascular diseases, blood dyscrasia, liver diseases, uncontrolled diabetes, etc.). to. Not smoking more than 10 cigarettes per day. f. Having a single rooted tooth of endodontic origin, with a periradicular lesion larger than 5 mm and smaller than 12 mm in diameter detected on periapical radiograph (chronic apical periodontitis), re-canal treatment planned and thought to be unsuccessful with re-canal treatment alone. Exclusion Criteria: Having ASA II-III-IV. Having a history of allergy to local anesthetics and drugs to be used. Presence of a systemic disease or drug use that may adversely affect postoperative wound healing and periodontal health. D. Being pregnant or lactating. to. Not using antiplatelet or anticoagulant drugs and having blood dyscrasias f. Smoking more than 10 cigarettes per day. g. Vertical root fracture, perforation in the furcation region, endo-perio lesion and more than 5 mm periodontal bone loss in the involved tooth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEYDA ERSAHAN, Assoc.Prof.
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University, Faculty of Dentistry
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Healing After Periradicular Surgery

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