Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay

Not Applicable

Not yet recruiting

• Conditions: Pulpitis - Reversible; Occlusal Caries; Proximal Caries

• Registration Number: NCT07171229
• Lead Sponsor: Cairo University

Brief Summary

pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels

Detailed Description

The proposed trial interventions, pulpotomy, will follow standard clinical procedural guidelines. Participants will be allocated to one of the two intervention groups only after intra-operative confirmation of pulp vitality and achievement of radicular pulp hemostasis.

Standard clinical protocol for both groups with occlusal and proximal decay:

1. A detailed history of symptoms will be obtained, and a thorough clinical examination will be conducted.

2. Pre-operative pain intensity will be assessed using a validated five-face visual analog scale (VAS), where children select the face that best represents their pain level.

3. A standard pre-operative periapical radiograph will be taken, ensuring the image extends beyond the root tip and shows no distortion or processing errors.

4. Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.

5. To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.

6. Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. to obtain pulpal blood samples. The specimens will be collected into heparin-coated tubes with 1 mg saline solution and stored at - 20 °C (-4.0 °F) for 6 months until the day of testing.

7. A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation. Intra-operative assessment of pulp vitality will be conducted, with healthy vital pulp appearing as uniformly reddish-pink vascular tissue and non-vital pulp as dark avascular tissue or yellowish liquefied areas. If necrotic, the tooth will be excluded from the study, and local management protocols will be followed for treatment (Bas et al., 2024).

8. MTA will be used as medicament of choice for pulpotomy.

9. Once a 2-3 mm thickness is ensured, the cavity will be filled with restorative glass ionomer cement to seal it.

10. The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.

Study Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Children with provoked pain.
• Caries in proximal surface to the dentine full thickness.
• Caries in occlusal surface to the dentine full thickness.
• Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.

Exclusion Criteria

• Unrestorable primary molars.
• Primary molars with spontaneous pain.
• Medically compromised patients who have systemic disease.
• Uncooperative children who refuse treatment.
• Children whose parents are unwilling to place stainless steel crowns.
• Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post operative Pain	pain will be measured at one week , 3 months , 6 months and 12 months.	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').; Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Preapical lesion	will be measured at 3 months , 6 months and 12 months	by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent )
Pain on percussion	will be measured at 3 months , 6 months and 12 months	Tapping the tooth with the blunt end of the mirror binary outcome: present or absent
Mobility	will be measured at 3 months , 6 months and 12 months	using Miller's mobility test :involves holding the tooth firmly between two instruments and assessing its mobility on a scale from 0 to 3. A score of 0 indicates no detectable movement, while scores of 1-3 represent increasing degrees of mobility.; it will be measured as present for any score from 1 to 3 (binary: present or absent)

Secondary Outcome Measures

Name	Time	Method
radiographic success	baseline data at the first visit following the procedure completion and at 6 and 12 months	using Digital periapical intraoral radiograph; Radiographic Success: • Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs.; Criteria for radiographic success; * No evidence of extensive pathologic root resorption.; * No evidence of pathological interradicular and/or periapical radiolucency.; * No evidence of the development of pathologic radiolucency involving the successor tooth germ.
Cytokines level	at the time of pulpotomy procedure	blood sample will be collected from exposed pulp chamber before removal and IL-8 \& IL-10 levels will be measured using Enzyme-linked immunoassay ( ELISA) kit. unit of measurement: ng/L

Trial Locations

Locations (1)

Cairo Univeristy; 🇪🇬 Cairo, Egypt