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

NCT ID: NCT07171229

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-10-01

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.

Conditions

Pulpitis - Reversible; Occlusal Caries; Proximal Caries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

occlusal decay

Primary molars diagnosed with reversible pulpits caused by occlusal decay

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: PROCEDURE

• Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
• To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
• Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s.
• A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation
• MTA will be used as medicament of choice for pulpotomy.
• The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.

Measuring Cytokines level

Intervention Type: OTHER

measuring cytokines level as an indicator for pulp inflammation

Proximal decay

Primary molars diagnosed with reversible pulpits caused by Proximal decay.

Group Type: ACTIVE_COMPARATOR

Pulpotomy

Intervention Type: PROCEDURE

• Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
• To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
• Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s.
• A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation
• MTA will be used as medicament of choice for pulpotomy.
• The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.

Measuring Cytokines level

Intervention Type: OTHER

measuring cytokines level as an indicator for pulp inflammation

Interventions

Pulpotomy

• Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
• To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
• Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s.
• A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation
• MTA will be used as medicament of choice for pulpotomy.
• The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.

Intervention Type: PROCEDURE

Measuring Cytokines level

measuring cytokines level as an indicator for pulp inflammation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Khalifa

PHD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany Saber

Role: STUDY_CHAIR

Professor of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy

Maii Mohammed

Role: STUDY_DIRECTOR

lecturer of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy

Yasmin Magdi Khalifa

Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo Univeristy

Cairo, , Egypt

Countries

Egypt

Central Contacts

Yasmin Ma Khalifa, PhD Candidate

Role: CONTACT

Ymkhalifa1991@gmail.com

+201000300634

Facility Contacts

Yasmin Magdi Khalifa

Role: primary

+201000300634

Other Identifiers

14422023529314

Identifier Type: -

Identifier Source: org_study_id