NCT04889196

Brief Summary

PICO question: In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars? population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome: Primary outcome: Gingival health measurement device modified gingival index, measurement unit score(0-1-2) Secondary outcomes:

  1. 1.Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
  2. 2.Time of Treatment measurement device digital chronometer, measurement unit minutes

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

May 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 1, 2021

Last Update Submit

May 14, 2021

Conditions

Caries

Outcome Measures

Primary Outcomes (3)

  • Gingival health

    Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying

    up to 1 day

  • Gingival health

    Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying

    at 3 months

  • Gingival health

    Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying

    at 6 months

Secondary Outcomes (5)

  • Oral hygiene

    up to one day

  • Oral hygiene

    at 3 months

  • Oral hygiene

    at 6 months

  • Treatment time

    during procedure

  • Treatment time

    during procedure in the second application at 6 monthes

Study Arms (2)

control group

ACTIVE COMPARATOR

The group that have caries in primary molars and treat them with hall technique

Device: hall technique

experimental group

EXPERIMENTAL

the group that have caries in primary molars and treat them with silver diamine fluoride (SDF) solution would exert a prevention result in managing early childhood caries ECC

Drug: Silver diamine fluoride

Interventions

Silver diamine fluorideDRUG

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

experimental group
hall techniqueDEVICE

The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method.

control group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: From 4 to 6 years
  • Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

You may not qualify if:

  • Tooth with signs and symptoms of pulp necrosis
  • Tooth with Root caries
  • Tooth with Spontaneous pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.

    PMID: 31158253RESULT

Related Links

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

  • sherif B Eltaeil, Prof

    Cairo University

    STUDY CHAIR

Central Study Contacts

Sarah A Abdalla, B.S.S

CONTACT

01064038625sarah.ibrahim@dentistry.cu.edu.eg

Ahmed B Elkhadem, Ass.Prof

CONTACT

01064440888Ahmed.Elkhadem@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 17, 2021

Study Start

September 1, 2021

Primary Completion

May 20, 2022

Study Completion

September 1, 2022

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share