The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars

NCT ID: NCT04889196

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-09-01

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. Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)

2. Time of Treatment measurement device digital chronometer, measurement unit minutes

Detailed Description

Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride 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

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)

Conditions

Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

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

Group Type: ACTIVE_COMPARATOR

hall technique

Intervention Type: DEVICE

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.

experimental group

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

Group Type: EXPERIMENTAL

Silver diamine fluoride

Intervention Type: DRUG

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)

Interventions

Silver diamine fluoride

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)

Intervention Type: DRUG

hall technique

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sarah Abdalla Ibrahim Abdalla

OTHER

Sponsor Role: lead

Responsible Party

Sarah Abdalla Ibrahim Abdalla

principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

sherif B Eltaeil, Prof

Role: STUDY_CHAIR

Cairo University

Central Contacts

Sarah A Abdalla, B.S.S

Role: CONTACT

sarah.ibrahim@dentistry.cu.edu.eg

01064038625 ext. 002

Ahmed B Elkhadem, Ass.Prof

Role: CONTACT

Ahmed.Elkhadem@dentistry.cu.edu.eg

01064440888 ext. 002

References

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.

Reference Type: RESULT

PMID: 31158253 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/31158253/

A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan.

Other Identifiers

120

Identifier Type: -

Identifier Source: org_study_id