NCT07196618

Brief Summary

This study was evaluated the effect of dimethyl sulfoxide pretreatment on tensile bond strength and nanoleakage of resin composite bonded to aged dentin.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 18, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 9, 2025

Last Update Submit

December 10, 2025

Conditions

Bonding

Outcome Measures

Primary Outcomes (1)

  • clinical assessment evaluation using the FDI world dental federation criteria

    post operative 2 weeks

Secondary Outcomes (1)

  • clinical assessment evaluation using the FDI world dental federation criteria

    post operative 3 months and 6 months

Study Arms (2)

DMSO

ACTIVE COMPARATOR
Drug: dimethyl sulfoxide

CHX

ACTIVE COMPARATOR
Drug: Cholorhexidine

Interventions

dimethyl sulfoxideDRUG

dentin pretreated using dimethyl sulfoxide and follow up of patients at 2 weeks, 3 months and 6 months

DMSO
CholorhexidineDRUG

dentin pretreated using chlorhexidine and follow up of patients at 2 weeks, 3months and 6 months

CHX

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included in the study will be required to present at least one of non caries cervical lesion with sclerotic dentin without pulpal involvement.
  • Age of patient: 50 - 75 years
  • Patients with non caries cervical lesion will be standardized by clinical performance (FDI world dental federation).

You may not qualify if:

  • Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
  • Developmental disorders and adjacent soft tissue lesions
  • Patients with systemic illness will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Interventions

Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

SulfoxidesSulfur CompoundsOrganic Chemicals

Study Officials

  • Aisha Zahran

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 9, 2025

First Posted

September 29, 2025

Study Start

September 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)