NCT06622018

Brief Summary

Tooth hypersensitivity is characterized by a transient short and sharp pain originating from exposed dentin in response to thermal, dehydrating, tactile, osmotic, and chemical stimuli. Tooth sensitivity after cementation of complete coverage crowns, is a rather common event since much of the protecting enamel is removed during preparation and a large area of dentin is exposed. Dentin contains up to two million tubules per cm2, which corresponds approximately to the surface area of most crown preparations. It is well known that such dentin wounds respond to mechanical, osmotic, or thermal stimulation with pain. This phenomenon is commonly example by the hydrodynamic theory of Brannstrom.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

September 28, 2024

Last Update Submit

September 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Desnsetizing agent Hypersensitivity

    Evaluation of the treated patients from hypersensitivity of the application of desnsetizing agent ( gluma and nanasaesheall) by using VAS score (from 0 to 10) as 0 is mean no sensitivity while 10 is the worst.

    from 0 hours to two weeks

Secondary Outcomes (1)

  • Dentinal tubule occlusion

    from 0 hours to two weeks

Study Arms (3)

Group A (Control Group)

PLACEBO COMPARATOR

About 11 patients with hypersensitive teeth of no treatment materials used

Procedure: Seashell Nanoparticles and Gluma Desensitizer

Group B(Seashell Nanoparticles Group)

ACTIVE COMPARATOR

About 11 patients with hypersensitive teeth faced treatment by sea shell nanoparticles

Procedure: Seashell Nanoparticles and Gluma Desensitizer

Group C (Gluma Group)

ACTIVE COMPARATOR

About 11 patients with hypersensitive teeth faced treatment by Gluma

Procedure: Seashell Nanoparticles and Gluma Desensitizer

Interventions

Evaluation the effect of Seashell Nano Particles and Gluma desensitizer on sensitivity of the teeth for Intra coronal restoration at different times

Also known as: Micromorphology
Group A (Control Group)Group B(Seashell Nanoparticles Group)Group C (Gluma Group)

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For patient Age between 25 and 40 years and no gender reference.
  • For the teeth Absence of pulpal exposure, RCT treatments, fracture and free of extensive caries (The amount of caries that can be removed during the preparation is acceptable

You may not qualify if:

  • For patients Use of desensitizing substances or drug like antihistamines, antidepressant 6 weeks before or during the study.
  • Requiring antibiotic prophylaxes or cortico-steriod therapy.
  • For teeth Tooth hypersensitivity prior to tooth preparation (like, abrasion or attration).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

gluma desensitizer

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Osama Saleh Abd El Ghani, Professor

    Al-Azhar Faculty of Dental Medicine for girls

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Dental Medicine

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 1, 2024

Study Start

January 10, 2023

Primary Completion

October 5, 2023

Study Completion

October 10, 2023

Last Updated

October 1, 2024

Record last verified: 2023-01

Locations