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

NCT ID: NCT07196293

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Customized Healing Abutment Dental Implant Composite Resin Peri-Implant Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard titanium healing abutment

standard titanium healing abutments used

Group Type NO_INTERVENTION

No interventions assigned to this group

customized healing abutment - bulk-fill flowable composite

Group Type ACTIVE_COMPARATOR

Customized Healing Abutment - bulk fill composite

Intervention Type PROCEDURE

instead of standard healing abutments , customization was done using bulk fill composite

customized healing abutment - Protemp 4 (Bis-Acryl composite)

Group Type ACTIVE_COMPARATOR

customized healing abutments - Bis acryl composite materials

Intervention Type PROCEDURE

customized healing abutments with bis acryl composite material was used instead of standard healing abutments

Interventions

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Customized Healing Abutment - bulk fill composite

instead of standard healing abutments , customization was done using bulk fill composite

Intervention Type PROCEDURE

customized healing abutments - Bis acryl composite materials

customized healing abutments with bis acryl composite material was used instead of standard healing abutments

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amrita Institute of Medical Sciences & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Bhavin Milind Patil

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amrita School Of Dentistry

Kochi, Kerala, India

Site Status

Countries

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India

Other Identifiers

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ECASM-AIMS-2023-356

Identifier Type: -

Identifier Source: org_study_id

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