Laser-Assisted Disinfection With and Without Photobiomodulation in Regenerative Endodontic Procedures for Necrotic Mature Teeth (LASER)
Radiographic and Clinical Evaluation of Regenerative Endodontic Procedures in Necrotic Mature Teeth With Apical Periodontitis Using Laser-Assisted Disinfection With and Without Adjunctive Photobiomodulation: A Three-Arm Randomized Clinical Trial
This study will compare three ways of treating adult teeth with a dead nerve (pulp) and an infection at the root tip. All three groups receive a regenerative endodontic procedure, which aims to help healthy tissue grow back inside the tooth. The groups differ in how the root canal is cleaned: (1) standard cleaning without a laser, (2) standard cleaning plus a diode laser to help disinfect the canal, or (3) standard cleaning plus the diode laser plus a single session of low-level light therapy (photobiomodulation) applied over the gum to support healing. Eighty-one patients aged 20 to 40 will be randomly placed into one of the three groups. Healing of the infection at the root tip will be measured with a 3D dental scan (CBCT) before treatment and 12 months later. Pain after treatment, painkiller use, and clinical signs such as swelling, tenderness, and gum pimples (sinus tract) will also be recorded. The study aims to find out whether adding laser treatment, with or without light therapy, improves healing.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: mohamed khalid, BDSc 2021
- Telefonszám: 0201100369000
- E-mail: mo.khalid.at@gmail.com
Tanulmányi helyek
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Cairo Governorate
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Cairo, Cairo Governorate, Egyiptom
- Future University in Egypt
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Kapcsolatba lépni:
- mohamed khalid
- Telefonszám: 02011003669000
- E-mail: m7mdd5alidd@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
- Good general health (ASA I or II)
- Aged 20 to 40 years
- Both sexes (male and female)
- Single-rooted mature permanent tooth
- Negative response to pulp sensibility testing (cold test)
- Periapical radiolucency ranging from widening of the lamina dura/periodontal ligament space up to a periapical lesion less than 5 mm in diameter on CBCT
- Restorable tooth with adequate remaining coronal structure and periodontal support
- Patient agrees to participate and is able to sign informed consent
Exclusion Criteria:
- Analgesic or antibiotic intake within 12 hours before the procedure
- Immature teeth
- Multi-rooted teeth
- Periapical lesion 5 mm or more in diameter
- Unrestorable teeth
- Teeth with vertical root fracture, extensive internal or external resorption, grade 2 or 3 mobility, or non-restorable coronal destruction
- Previous root canal treatment
- Systemic conditions or medications affecting healing (for example uncontrolled diabetes, immunosuppression, bisphosphonate therapy)
- Pregnant or lactating patients
- Unable to understand the procedure, provide valid consent, or comply with follow-up
- Known allergy to the irrigants or medicaments used in the protocol
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: REP's with no laser disinfection (control)
Regenerative endodontic procedure (REP) with conventional chemomechanical preparation only (2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, and sterile saline), followed by a calcium hydroxide intracanal dressing for 2 weeks. At the second visit: EDTA irrigation, induced apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal. No laser is used. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. |
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Kísérleti: REP's with laser-assisted disinfection, using adjunctive 810 nm diode laser irradiation.
Same REP protocol as the control group, with the addition of 810 nm diode laser disinfection at the first visit after the final saline rinse and before the calcium hydroxide dressing. Continuous wave mode, 1.5 W, 4 cycles of 5 seconds with 20-second intervals, using a 200 micrometer fiber placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal. The canal is irrigated with 5 mL saline after each cycle. The second visit is identical to the control group. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. Adjunctive canal disinfection at the first visit using an 810 nm diode laser (Elexxion, Germany), continuous wave, 1.5 W, 4 cycles of 5 seconds with 20-second intervals. A 200 micrometer fiber is placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal at about 2 mm per second without touching the canal walls. The canal is irrigated with 5 mL sterile saline after each cycle. |
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Kísérleti: REP's with Laser-assisted disinfection and adjunctive photobiomodulation,
Same protocol as the laser-assisted disinfection group, plus a single session of transmucosal photobiomodulation (PBM) delivered at the second visit immediately after placement of the blood scaffold and coronal restoration. 810 nm diode laser, continuous wave, 200 mW, 8 mm tip in contact with the mucosa, applied at four sites per tooth (periapical and cervical regions on the buccal and lingual/palatal sides), 15 seconds and 3 J per site, for a total of 12 J per tooth. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. Adjunctive canal disinfection at the first visit using an 810 nm diode laser (Elexxion, Germany), continuous wave, 1.5 W, 4 cycles of 5 seconds with 20-second intervals. A 200 micrometer fiber is placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal at about 2 mm per second without touching the canal walls. The canal is irrigated with 5 mL sterile saline after each cycle. Single session of transmucosal photobiomodulation at the second visit, immediately after placement of the blood scaffold and coronal restoration. 810 nm diode laser, continuous wave, 200 mW, 8 mm tip in contact with the mucosa. Four sites per tooth (periapical and cervical regions on the buccal and lingual/palatal sides), 15 seconds and 3 J per site, for a total of 12 J per tooth. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in periapical lesion volume (mm3) measured on CBCT
Időkeret: baseline and 12 month
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Periapical lesion volume in cubic millimeters measured on cone-beam computed tomography (CBCT) scans (field of view 50 x 50 mm, isometric voxel size 0.125 mm) by a blinded outcome assessor. Change from baseline to 12 months is compared among the three groups. |
baseline and 12 month
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Postoperative pain intensity (Numeric Rating Scale)
Időkeret: Preoperative (baseline), 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Patient-reported pain on the Numeric Rating Scale from 0 (no pain) to 10 (worst pain imaginable), collected by telephone by a blinded study coordinator. |
Preoperative (baseline), 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Postoperative analgesic intake
Időkeret: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Whether any analgesic was taken since the previous assessment, with the number of doses and dose per intake, recorded at each telephone contact. |
6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Resolution of clinical signs and symptoms
Időkeret: Preoperative (baseline), second visit, 3 months, 6 months, and 12 months
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Presence or absence of tenderness to percussion, tenderness to palpation, swelling, and sinus tract, and need for additional intervention, assessed by clinical examination by a blinded examiner. |
Preoperative (baseline), second visit, 3 months, 6 months, and 12 months
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- FUE-ENDO-REP-LASER-2026
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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