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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth

1 november 2026 bijgewerkt door: Ipek Eraslan Akyuz, TC Erciyes University

PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth: A Clinical Trial

This clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.

Ten participants will be included, and each participant will contribute two eligible single-rooted, single-canal teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the other tooth will receive conventional root canal treatment.

The primary objective is to compare radiographic periapical healing between the two treatments at 12 months. Secondary outcomes will include postoperative pain, analgesic use, clinical signs and symptoms, pulp sensibility, treatment success, tooth survival, and adverse events. Clinical and radiographic follow-up will be performed at 6, 12, and 24 months.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This prospective, single-center, within-patient clinical trial will evaluate platelet-rich plasma (PRP)-assisted regenerative endodontic treatment compared with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.

Ten participants will be enrolled, and each participant will contribute two eligible mature, single-rooted, single-canal permanent teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the paired tooth will receive conventional root canal treatment. This paired design allows each participant to serve as his or her own control and is intended to reduce the influence of interindividual variability.

Both study teeth will undergo standardized chemomechanical preparation, irrigation, intracanal medication with calcium hydroxide, and a second treatment visit. In the PRP-assisted regenerative treatment arm, autologous PRP will be prepared from venous blood and introduced into the root canal after controlled apical stimulation. A bioceramic coronal barrier will then be placed, followed by definitive coronal restoration. In the conventional root canal treatment arm, the canal will be obturated with gutta-percha and bioceramic sealer and definitively restored.

Postoperative pain will be recorded separately for each study tooth at 6, 12, 24, and 48 hours and on days 3 through 7. Analgesic use will also be recorded.

Clinical and radiographic follow-up will be performed at 6, 12, and 24 months. The primary outcome will be radiographic periapical healing at 12 months, expressed as the percentage reduction in standardized periapical lesion area relative to baseline. Secondary outcomes will include postoperative pain trajectory, analgesic consumption, Periapical Index scores, complete radiographic healing, clinical success, cold and electric pulp sensibility responses, tooth survival, and adverse events.

Radiographic assessments will be performed using standardized periapical radiographs. Outcome assessors will be blinded to treatment allocation, and radiographic measurements will be performed by calibrated examiners.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Turkije (Türkiye), 38039
        • Erciyes University Faculty of Dentistry
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 18-45 years.
  • ASA physical status I or II.
  • Two restorable mature permanent teeth suitable for paired allocation.
  • Single-rooted, single-canal anatomy.
  • Closed apices and completed root development.
  • Diagnosis of pulp necrosis.
  • Radiographic evidence of apical periodontitis.
  • Periapical Index (PAI) score ≥3 for both study teeth.
  • Periapical radiolucency ≥5 mm at its greatest radiographic dimension for both study teeth.
  • Periodontal probing depth ≤3 mm and absence of advanced periodontal disease.
  • Absence of pathological mobility.
  • Adequate coronal tooth structure for definitive restoration and feasibility of rubber-dam isolation.
  • Ability and willingness to complete postoperative pain records and attend 6-, 12-, and 24-month follow-up visits.

Exclusion Criteria:

  • Previous root canal treatment or previous endodontic surgery in either study tooth.
  • More than one root or more than one root canal.
  • Open apex, developmental anomaly, internal or external root resorption, root fracture, or suspected vertical root fracture.
  • Severe canal curvature or anatomy incompatible with standardized instrumentation.
  • Non-restorable tooth or inability to obtain adequate isolation.
  • Periodontal attachment loss or periodontal probing depth >3 mm.
  • Pregnancy or breastfeeding.
  • Systemic disease or medication likely to substantially alter inflammation, coagulation, pain perception, or healing.
  • Use of analgesics, anti-inflammatory drugs, systemic corticosteroids, or antibiotics within the predefined preoperative period.
  • Inability to comply with postoperative or long-term follow-up.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PRP-Assisted Regenerative Endodontic Treatment

Participants will receive PRP-assisted regenerative endodontic treatment in one eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma will be prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier will then be placed, followed by definitive resin composite restoration.
Procedure: PRP-Assisted Regenerative Endodontic Treatment

After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma is prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier is placed, followed by definitive resin composite restoration.
Actieve vergelijker: Conventional Root Canal Treatment

Participants will receive conventional root canal treatment in the paired eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the canal will be obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity will then be definitively restored with resin composite.
Procedure: Conventional Root Canal Treatment

After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the root canal is obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity is then definitively restored with resin composite.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage Reduction in Periapical Lesion Area
Tijdsspanne: Baseline to 12 months

Periapical lesion area will be measured on standardized digital periapical radiographs by calibrated blinded examiners using validated image-analysis software. Percentage lesion reduction will be calculated as [(baseline lesion area - 12-month lesion area) / baseline lesion area] × 100. Higher percentage values indicate greater radiographic healing.
Baseline to 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Pain Intensity
Tijdsspanne: 6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment

Postoperative pain will be recorded separately for each study tooth using a 100-mm visual analogue scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Participants will record tooth-specific pain scores at each predefined postoperative time point.
6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
Analgesic Consumption
Tijdsspanne: From treatment through postoperative day 7

Analgesic use will be recorded for each study tooth during the postoperative follow-up period. Participants will record the time and number of analgesic doses taken. Ibuprofen 400 mg will be recommended when required, with paracetamol 500 mg used when ibuprofen is contraindicated.
From treatment through postoperative day 7
Periapical Index Score
Tijdsspanne: 6, 12, and 24 months

Periapical healing will be assessed using the Periapical Index (PAI) on standardized periapical radiographs. PAI scores will be determined by calibrated blinded examiners at each follow-up visit.
6, 12, and 24 months
Complete Radiographic Healing
Tijdsspanne: 6, 12, and 24 months

Complete radiographic healing will be assessed on standardized periapical radiographs by calibrated blinded examiners. Complete healing will be recorded when the periapical radiolucency has resolved and no radiographic evidence of progressive periapical disease is present.
6, 12, and 24 months
Clinical Success
Tijdsspanne: 6, 12, and 24 months

Clinical success will be defined as a functional tooth without spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, or evidence of progressive periapical disease. Teeth requiring nonsurgical retreatment, endodontic surgery, extraction, or another intervention because of persistent endodontic disease will be classified as failures.
6, 12, and 24 months
Pulp Sensibility Response
Tijdsspanne: 6, 12, and 24 months

Pulp sensibility will be assessed using cold testing and electric pulp testing at follow-up visits. A positive response to either sensibility test will be recorded for each study tooth.
6, 12, and 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

TC Erciyes University

Onderzoekers

  • Hoofdonderzoeker: ipek eraslan akyüz, DDS, TC Erciyes University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 juni 2029

Studieregistratiedata

Eerst ingediend

1 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 november 2026

Eerst geplaatst (Werkelijk)

5 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

1 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ERU-ENDO-PRPREP-RCT-2026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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