NCT07715383

Brief Summary

Restorative materials play a crucial role in dental treatments, particularly in managing tooth decay and restoring damaged teeth. Their interaction with dental pulp is significant, especially in cases where pulp inflammation is present. When a tooth is compromised, the choice of restorative material can influence the health of the pulp. Certain materials can promote healing and reduce inflammation, while others may exacerbate the condition. For instance, biocompatible materials like glass ionomer or resin-modified glass ionomer have been shown to provide a favorable environment for pulp cells, potentially aiding in the regeneration of dental pulp tissue. Conversely, materials that are not well-tolerated may lead to further irritation and inflammation, highlighting the importance of selecting appropriate restorative materials to protect pulp vitality and support overall dental health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (1)

  • Measuring Pulpal inflammatory responses

    (Analysis of the crevicular fluid) (TNF Alpha \& IL1) after using two different filling materials and techniques.

    1 month

Secondary Outcomes (1)

  • Post-operative pain

    1 to 6 days

Study Arms (3)

Surface pre-reacted glass ionomer based injectable composite

ACTIVE COMPARATOR

Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Surface pre-reacted glass ionomer based injectable composite 10 patient per group

Procedure: Bioactive Restorative Materials

Resin modified glass ionomer

ACTIVE COMPARATOR

Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Resin modified glass ionomer 10 patient per group

Procedure: Bioactive Restorative Materials

Cention forte

ACTIVE COMPARATOR

Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Cention forte 10 patient per group

Procedure: Bioactive Restorative Materials

Interventions

Bioactive Restorative MaterialsPROCEDURE

To evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels

Also known as: Techniques
Cention forteResin modified glass ionomerSurface pre-reacted glass ionomer based injectable composite

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Simple occlusal deep carious lesions.
  • ICDAS 5 and 6.
  • No restorations with the related teeth.
  • Periodontally healthy patient (no bleeding on probing and no radiographic evidence of periodontal bone loss)
  • Normal occlusion.
  • Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.

You may not qualify if:

  • Vulnerable groups such as pregnant females, breast feeding, prisoners, mentally ill, etc.…
  • Cigarette smoking or any form of tobacco consumption.
  • Medically compromised patients as diabetes.
  • A previously endo treated teeth.
  • Ongoing dental or periodontal treatment 12 months before the beginning of the study.
  • Presence of periodontal pockets \>3 mm in the affected tooth.
  • Antibiotics or any medication that might lead to decreased salivary flow.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Medhat Taha EL-Faramawy, M.D

    Professor of Endodontics, Faculty of Dentistry, Ain shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching Assistant at Department of Endodontics, Faculty of Dentistry

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start

March 15, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

July 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)