NCT05847647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 1, 2023

Last Update Submit

February 24, 2026

Conditions

Apical PeriodontitisPeriapical Lesion

Outcome Measures

Primary Outcomes (1)

  • 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: 1. PAI 1: normal periapical structure 2. PAI 2: small changes in the bone structure not pathognomonic of apical periodontitis 3. PAI 3: changes in the bone structure with mineral loss characteristic of apical periodontitis 4. PAI 4: well-defined apical radiolucency characteristic of apical periodontitis 5. PAI 5: severe periodontitis with exacerbating features and bone expansion

    an average of 1 year

Study Arms (4)

1. group: Retrograde Filling Group / RG Group

EXPERIMENTAL

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

Other: Retrograde Filling Group

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

EXPERIMENTAL

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.

Other: Retrograde Filling+L-PRF Group

3. Group: Orthograde Filling Group / OG Group

EXPERIMENTAL

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.

Other: (Orthograde Filling Group / OG Group).

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

EXPERIMENTAL

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.

Other: (Orthograde Filling+L-PRF Group

Interventions

Retrograde Filling GroupOTHER

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.

1. group: Retrograde Filling Group / RG Group
Retrograde Filling+L-PRF GroupOTHER

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 (

2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group
(Orthograde Filling Group / OG Group).OTHER

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

3. Group: Orthograde Filling Group / OG Group
(Orthograde Filling+L-PRF GroupOTHER

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

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Gulsever S, Ersahan S, Hepsenoglu YE, Tekin A. Apicoectomy versus apical curettage in combination with or without L-PRF application: a randomized clinical trial. Sci Rep. 2025 Mar 8;15(1):8121. doi: 10.1038/s41598-025-92787-y.

    PMID: 40057596DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • SEYDA ERSAHAN, Assoc.Prof.

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

February 1, 2023

First Posted

May 6, 2023

Study Start

February 7, 2022

Primary Completion

March 2, 2023

Study Completion

September 2, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

TU(1)