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

NCT07171229 | Not Yet Recruiting

• 1 other identifier: 14422023529314
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Pulpitis - Reversible; Occlusal Caries; Proximal Caries

Keywords

pulpotomy; cytokines

Outcome Measures

Primary Outcomes (4)

• Post operative Pain

  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).

  pain will be measured at one week , 3 months , 6 months and 12 months.

• Preapical lesion

  by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent )

  will be measured at 3 months , 6 months and 12 months

• Pain on percussion

  Tapping the tooth with the blunt end of the mirror binary outcome: present or absent

  will be measured at 3 months , 6 months and 12 months

• Mobility

  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)

  will be measured at 3 months , 6 months and 12 months

Secondary Outcomes (2)

• radiographic success

  baseline data at the first visit following the procedure completion and at 6 and 12 months

• Cytokines level

  at the time of pulpotomy procedure

Study Arms (2)

occlusal decay

EXPERIMENTAL

Primary molars diagnosed with reversible pulpits caused by occlusal decay

Procedure: Pulpotomy; Other: Measuring Cytokines level

Proximal decay

ACTIVE COMPARATOR

Primary molars diagnosed with reversible pulpits caused by Proximal decay.

Procedure: Pulpotomy; Other: Measuring Cytokines level

Interventions

Pulpotomy 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.

Proximal decay; occlusal decay

Measuring Cytokines level OTHER

measuring cytokines level as an indicator for pulp inflammation

Proximal decay; occlusal decay

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univeristy

Cairo, Egypt

Location

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Hany Saber

  Professor of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy

  STUDY CHAIR

• Maii Mohammed

  lecturer of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy

  STUDY DIRECTOR

• Yasmin Magdi Khalifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Ma Khalifa, PhD Candidate

CONTACT

+201000300634; Ymkhalifa1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD candidate

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)