Ultrasonic Activated Irrigation and Intracanal Cryotherapy for Reducing Pain After Root Canal Treatment
Effect of Using Ultrasonic Activated Irrigation, With and Without Intracanal Cryotherapy, on Post-Operative Pain After Single Visit Root Canal Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
Participants requiring root canal treatment will be randomly allocated into two groups. One group will receive ultrasonic activated irrigation alone, while the other group will receive ultrasonic activated irrigation followed by intracanal cryotherapy. Postoperative pain will be assessed at predetermined time intervals using a standardized pain assessment scale.
The findings of this study may help identify effective strategies for reducing postoperative pain after root canal treatment and improving patient comfort and treatment outcomes.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Postoperative pain remains one of the most common complications following root canal treatment and may negatively affect patient comfort and treatment acceptance. Various factors, including preoperative status, instrumentation techniques, and irrigation protocols, influence the incidence and severity of post-endodontic pain.
Ultrasonic activated irrigation (UAI) enhances the effectiveness of irrigants by generating acoustic streaming and cavitation, thereby improving debris removal, smear layer elimination, and disinfectant penetration into the root canal system. Intracanal cryotherapy, which involves the application of cold saline as a final irrigant, has been proposed as a non-pharmacological method to reduce postoperative pain by decreasing tissue temperature and exerting anti-inflammatory effects.
This study is a single-center, parallel two-arm, single-blinded randomized controlled trial conducted at the Department of Operative Dentistry and Endodontics, Sardar Begum Dental College, Peshawar, Pakistan. A total of 60 patients aged 20 to 50 years diagnosed with symptomatic irreversible pulpitis in mandibular first or second molars will be enrolled.
Eligible participants will be randomly allocated into two groups using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Group A (control group) will receive ultrasonic activated irrigation without intracanal cryotherapy, whereas Group B (intervention group) will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes.
All treatments will be performed in a single visit under local anesthesia and rubber dam isolation using standardized clinical protocols. Root canal preparation will be carried out using the ProTaper Universal rotary system. Ultrasonic activation will be performed for one minute per canal. Following obturation and permanent restoration, postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS).
Pain scores will be recorded at 12, 24, 48, and 72 hours postoperatively through telephone follow-up by a blinded assessor. The primary outcome measure is postoperative pain intensity. Analgesic consumption and adverse events will also be documented.
The findings of this study may provide evidence regarding the effectiveness of intracanal cryotherapy as an adjunct to ultrasonic activated irrigation for reducing postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
1. Patients who are medically fit (ASA Physical Status I) and aged between 20 and 50 years will be recruited for the study.
2. Mandibular first or second molars exhibiting signs of symptomatic irreversible pulpitis, identified through an extended sensitivity to cold testing and/or a positive electric pulp test.
3.Vital pulp with no signs of apical pathology (normal periapical radiograph, no swelling, sinus tract, or mobility).
4. Mature roots with closed apices and no prior root canal treatment. 5. Willing to undergo single-visit treatment and comply with follow-up.
Exclusion Criteria:
1.Use of analgesics or NSAIDs within 12 hours prior to treatment. 2.Pregnant or lactating women. 3.Presence of systemic illness or allergy to any materials used in the study. 4.Teeth with:
- Non-vital pulp, periapical radiolucency, or sinus tract.
- Mobility > Grade I or periodontal pockets > 5 mm.
- Resorption, calcification, or non-restorable crown structure. 5.Third molars (wisdom teeth). 6.Endodontically treated tooth. 7.Inability or unwillingness to follow study instructions or complete follow-up.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Ultrasonic Activated Irrigation Without Intracanal Cryorherapy
Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation.
Root canal preparation will be performed using the ProTaper Universal rotary system.
Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal.
At the final irrigation stage, 10 mL of room-temperature 0.9% saline will be delivered over 5 minutes.
The canals will then be obturated and permanently restored in the same visit.
|
Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.
|
|
Experimental: Ultrasonic Activated Irrigation With Intracanal Cryotherapy
Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation.
Root canal preparation will be performed using the ProTaper Universal rotary system.
Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal.
At the final irrigation stage, 10 mL of cold (1.5-2.5°C)
0.9% saline will be delivered 1 mm short of the working length over 5 minutes as intracanal cryotherapy.
The canals will then be obturated and permanently restored in the same visit.
|
Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.
Intracanal cryotherapy was performed by delivering 10 mL of cold 0.9% saline (1.5-2.5°C)
passively 1 mm short of the working length over 5 minutes as the final irrigation step during single-visit root canal treatment.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative Pain Intensity
Zeitfenster: 12,24,48 and 72 hours after the completion of single-visit root canal treatment
|
Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS).
Pain scores will be recorded through telephone follow-up at 12, 24, 48, and 72 hours after completion of single-visit root canal treatment.
|
12,24,48 and 72 hours after the completion of single-visit root canal treatment
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Shakeel Ur Rehman Khattak, BDS,BSc,MHR,FCPS, Sardar Begum Dental College,Gandhara University,Peshawar,Pakitstan
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GU/Ethical Committee/2025/248
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