An interventional study of Dia-Root Bio MTA Indirect Pulp Capping and MTA Plus Indirect Pulp Capping in MTA, Pulp Caping and Permanent Molars, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This split-mouth randomized controlled clinical trial evaluates and compares the clinical and radiographic success of Dia-Root Bio MTA versus conventional Mineral Trioxide Aggregate (MTA Plus) as indirect pulp capping (IPC) materials in young permanent molars.
Twenty pediatric patients aged 6 to 9 years with bilateral deeply carious mandibular first permanent molars requiring indirect pulp capping are enrolled (n = 40 molars total). Following selective caries removal to soft dentin and preservation of affected dentin, target molars are randomly allocated in a split-mouth design to receive either Dia-Root Bio MTA (Group I) or MTA Plus (Group II) capped with glass ionomer base and composite resin restorations. Postoperative clinical pain is tracked using a 4-point facial pain intensity scale over the first 48 hours. Clinical success (absence of tenderness, swelling, fistula, or pathological mobility) and radiographic parameters (dentine bridge/dentin thickness formation, radiodensity changes, and absence of root resorption) are evaluated at 3, 6, and 9 months post-operative.
Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Asymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using Dia-Root Bio MTA paste prior to final composite restoration.
Procedure: Dia-Root Bio MTA Indirect Pulp Capping
Asymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using MTA Plus prior to final composite restoration.
Procedure: MTA Plus Indirect Pulp Capping
Preparation: Administration of 4% Articaine local anesthesia with epinephrine, rubber dam isolation, high-speed cavity preparation to non-carious dentin at lateral walls, and selective excavation of soft carious dentin at the pulpal floor using a manual excavator (leaving firm affected dentin). Cavity flushed with saline for 10 seconds and air-dried. Capping \& Restoration: Dia-Root Bio MTA mixed with sterile distilled water (0.225g : 0.5g powder ratio) for 30 seconds, placed over residual dentin at 3-4 mm thickness, and condensed with a moist cotton pellet. Cavity sealed immediately with glass ionomer cement base (Nova Glass) and restored with composite resin (Tetric N Ceram).
Preparation: Identical local anesthesia, rubber dam isolation, lateral wall caries excavation, and selective soft dentin excavation at the pulpal floor, saline flush, and air-drying. Capping \& Restoration: MTA Plus mixed with sterile distilled water to putty consistency, placed over residual dentin at 3-4 mm thickness, condensed with a moist cotton pellet, sealed immediately with glass ionomer base, and restored with identical composite resin.
Cumulative Clinical Success Rate
Binary clinical evaluation (Success/Failure) defined as the complete absence of clinical signs and symptoms of pulpal/periapical pathology: Absence of tenderness to percussion or mastication. Absence of gingival swelling, abscess, or fistulous tract. Absence of pathological tooth mobility.
Time frame: 3 months, 6 months, and 9 months post-operative.
Radiographic Success Rate and Dentin Bridge Formation
Radiographic evaluation on standardized digital periapical radiographs to verify: Presence/increase in newly formed tertiary dentin thickness under the capping material. Radiodensity changes of affected dentin at the pulpal floor. Complete absence of internal/external root resorption or periapical radiolucency.
Time frame: Baseline (immediate post-operative), 3 months, 6 months, and 9 months post-operative.
Early Postoperative Pain Intensity
Postoperative pain self-reported by the child/parent using a standardized 4-point facial pain intensity rating scale categorized as: 1. No pain 2. Slight pain 3. Moderate pain 4. Severe pain
Time frame: 6 hours, 12 hours, 24 hours, and 48 hours post-procedure.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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