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Apical PeriodontitisNCT05847647

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

A study testing Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group). in people with Apical Periodontitis and Periapical Lesion, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Apical Periodontitis, Periapical Lesion
What is being tested?
Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Feb 2022to 2 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University, Faculty of Dentistry

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Clinical and Radiographic Healing After Periradicular Surgery: Randomized Controlled Clinical Trial.

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.

Read the 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:

  1. 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).
  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 (Retrograde Filling+L-PRF Group / RG+L-PRF Group).
  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 (Orthograde Filling Group / OG Group).
  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 (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.

Being tested
Retrograde Filling Group, Retrograde Filling+L-PRF Group, (Orthograde Filling Group / OG Group)., (Orthograde Filling+L-PRF Group
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Retrograde Filling+L-PRF GroupOther

    1. 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 (
  • (Orthograde Filling Group / OG Group).Other

    1. 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+L-PRF GroupOther

    1. 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
Study groups in NCT05847647
Study groupRoleWhat they receive
1. group: Retrograde Filling Group / RG GroupExperimentalSurgical 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
Receives: Other: Retrograde Filling Group
2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF GroupExperimentalSurgical 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.
Receives: Other: Retrograde Filling+L-PRF Group
3. Group: Orthograde Filling Group / OG GroupExperimentalSurgical 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.
Receives: Other: (Orthograde Filling Group / OG Group).
4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF GroupExperimentalSurgical 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.
Receives: Other: (Orthograde Filling+L-PRF Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start7 Feb 2022
  3. Primary completion2 Mar 2023
  4. Study completion2 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847647
Sponsor's protocol ID
periradicular surgery
Status last verified
Feb 2026
First submitted
1 Feb 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40057596

Questions about this trial

What is this clinical trial studying?

A study testing Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group). in people with Apical Periodontitis and Periapical Lesion, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apical lesion healing (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05847647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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