Layering Technique Selection for Ultimate Aesthetics in Anterior Composites

NCT02999880 | Unknown DMC

• 1 other identifier: CEBD-CU-2016-10-237
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

the importance of this study is to evaluate the clinical performance of direct anterior resin composite restoration constructed using innovative esthetic dual-shade technique and another restoration constructed using polychromatic natural layering technique with various finishing and polishing steps. The benefit from carrying out this study is to help the practitioners to decide the most suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with superior clinical performance direct anterior resin composite restoration.

Conditions

Poor Aesthetics of Existing Restoration

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.

  Change in satisfaction from baseline, after6 months and 0ne year

Secondary Outcomes (1)

• Color shade

  change in shade from baseline, after six months and one year

Other Outcomes (1)

• Clinical performance including anatomic form, marginal discoloration,surface roughness, marginal adaptation and recurrent caries.

  change from baseline, after six months and one year

Study Arms (2)

Polychromatic layering (Control):

EXPERIMENTAL

Using and mixing different composite shades, opalescents and intensives.

Procedure: Polychromatic layering

Dual-shade layering (Intervention):

NO INTERVENTION

Only two composite resin material shades the opaque dentin composite and enamel shade composite.

Interventions

Polychromatic layering PROCEDURE

Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).

Polychromatic layering (Control):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with good general health.
• Patients who will agree to the consent and will commit to follow-up period.
• Fully erupted anterior teeth with defects.
• Active caries, fractures, or defective Restorations in 6 anterior teeth.
• At least one spot lesion for contra-lateral anterior teeth on each side in the same jaw

You may not qualify if:

• Patients with any systemic disease that may affect normal healing.
• Patient with bad oral hygiene.
• Tetracycline or florsis staining.
• Patients who could/would not participate in all times of follow-up.
• Untreated periodontal disease was not allowed.
• Patients participating in more than 1 dental study.
• Patient received fluoride varnish during orthodontic treatment.
• Fully erupted anterior teeth with no defects.
• Patients with tendency to do bleaching during the study.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 21, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share