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A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant

A

Amrita Institute of Medical Sciences & Research Center

Status

Completed

Conditions

Composite Resin
Customized Healing Abutment
Peri-Implant Health
Dental Implant

Treatments

Procedure: customized healing abutments - Bis acryl composite materials
Procedure: Customized Healing Abutment - bulk fill composite

Study type

Interventional

Funder types

Other

Identifiers

NCT07196293
ECASM-AIMS-2023-356

Details and patient eligibility

About

The study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. The research aims to evaluate and compare the effectiveness of two common, cost-effective dental materials-light-cure composite and Protemp (a bis-acryl composite resin)-for fabricating customized healing abutments. By assessing the peri-implant tissue response to these materials, the study seeks to determine which is more suitable for creating an optimal, natural-looking soft tissue contour, thereby providing dentists with a practical and reliable alternative to more expensive options like PEEK.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 18 and 65 years.
  • Edentulous spaces to be replaced with implant-supported single crowns.
  • Antagonistic natural tooth present and sound (sound periodontium) (Stable occlusion and opposing dentition)
  • Good general periodontal health
  • Good general health.
  • Willing to participate in the study and able to sign informed consent. (Ability to attend all follow-up appointments.)

Exclusion criteria

  • Untreated caries or periapical lesions in the opposing natural antagonistic tooth.
  • Active periodontal disease.
  • major active systemic disease affecting soft tissue healing
  • Multiple implant supported restorations already present.
  • Long edentulous spaces.
  • Complete edentulous cases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

standard titanium healing abutment
No Intervention group
Description:
standard titanium healing abutments used
customized healing abutment - bulk-fill flowable composite
Active Comparator group
Treatment:
Procedure: Customized Healing Abutment - bulk fill composite
customized healing abutment - Protemp 4 (Bis-Acryl composite)
Active Comparator group
Treatment:
Procedure: customized healing abutments - Bis acryl composite materials

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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