Hypertonic Saline as a Final Flush and Post-Operative Pain After Single Visit Root Canal Treatment in Mandibular Premolar.

Официальное название

Effect of Hypertonic Saline (3%) as a Final Flush Irrigant on Post-Operative Pain and Substance P Expression Following Single-Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis Related to Mandibular Premolars: A Randomized Controlled Trial

Обзор

This randomized controlled trial evaluates whether a final flush with 3% hypertonic saline, compared with 0.9% normal saline, reduces post-operative pain and periapical Substance P (SP) levels after single-visit root canal treatment in mandibular premolars with symptomatic irreversible pulpitis. Forty adult patients will be randomized 1:1. Pain will be measured with the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours post-operatively. Periapical fluid SP levels will be measured by ELISA at two intra-operative time points (after working length determination, and after the final flush). The number of ibuprofen 400 mg tablets consumed within 24-48 hours will also be recorded.

Подробное описание

Post-operative endodontic pain is linked to periapical release of Substance P (SP), a neuropeptide that sustains neurogenic inflammation via NK-1 receptor binding. 3% hypertonic saline has documented osmotic decongestant and NF-κB-mediated anti-inflammatory/cytokine-suppressive effects in non-dental models, providing biological rationale for its use as a final irrigant. This is a two-arm, parallel-group, participant- and assessor-blinded RCT conducted at the outpatient endodontic clinic, Faculty of Dentistry, Cairo University. After standardized access, working length determination, and a baseline periapical fluid sample (S1), canals will be shaped with continuous rotary NiTi instrumentation and irrigated with 2.5% NaOCl. After smear layer removal (2.5% NaOCl then 17% EDTA), participants receive a final flush of either 5 mL 0.9% normal saline (control) or 5 mL 3% hypertonic saline (intervention), delivered via a 30-gauge side-vented needle 2 mm short of working length. A second periapical fluid sample (S2) is then collected. Canals are obturated by lateral compaction in the same visit. Participants record VAS pain scores pre-operatively and at 6, 12, 24, and 48 hours, and log ibuprofen 400 mg tablet consumption at 24 and 48 hours. SP will be quantified from S1/S2 samples by ELISA, blinded to group allocation.

Вмешательства

• Препарат Normal (0.9%) saline
  Isotonic 0.9% NaCl solution used as final canal flush, no pharmacological activity
• Препарат Hypertonic 3% saline
  Osmotic/anti-inflammatory final irrigant hypothesized to reduce periapical edema and suppress pro-inflammatory cytokine-mediated SP release via NF-κB pathway inhibition.

Первичные конечные точки

• Post-operative pain intensity at 6 hours [Срок оценки: 6 hours post-operatively]

Вторичные конечные точки (3)

• Post-operative pain intensity at 12, 24, and 48 hours [Срок оценки: 12, 24, and 48 hours post-operatively]
• Change in periapical Substance P expression (ΔSP = S2 - S1) [Срок оценки: S1 = after working length determination (intra-operative); S2 = immediately after final flush (intra-operative)]
• Number of rescue analgesic tablets consumed [Срок оценки: 24 and 48 hours post-operatively]

Критерии участия

Критерии включения

• Age 18-60 years, any sex
• Systemically healthy
• Mandibular premolar with clinically/radiographically diagnosed symptomatic irreversible pulpitis (prolonged, exaggerated response to cold testing; no periapical radiolucency)
• Able to use the VAS scale and complete follow-up

Критерии исключения

• Medically compromised patients
• Pregnant or lactating women
• Allergy/hypersensitivity to local anesthetics or NSAIDs
• Analgesics, anti-inflammatories, or antibiotics within 12 hours pre-treatment
• Vertical root fracture, root resorption, or previous RCT
• Radiographic periapical pathology
• Non-restorable teeth
• TMD, bruxism, or traumatic occlusion interfering with pain assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07701551 · ENDO 3.3.3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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