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NCT Number: NCT07196293

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

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.

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Key information

Conditions

Customized Healing Abutment Composite Resin Dental Implant Peri-Implant Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amrita School Of Dentistry

Kochi, Kerala, 682041, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Customized Healing Abutment - bulk fill composite

Procedure

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

customized healing abutments - Bis acryl composite materials

Procedure

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

Primary outcomes

  1. Gingival Index (GI)

    Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.

    Gingival Index (GI): This index is used to evaluate inflammation of the gums around the implant.

    Scale: 0 to 3.

    Interpretation: A higher score indicates a worse outcome, signifying greater gingival inflammation.

  2. Probing depth (PI)

    Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.

    Probing Depth (PD): This is a direct clinical measurement, not a scored scale, taken in millimeters at six points around the implant.

    Interpretation: Deeper measurements are generally associated with less healthy peri-implant tissue. Therefore, a lower value indicates a better clinical outcome.

  3. Pink Esthetic Score (PES)

    Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.

    Pink Esthetic Score (PES): This score is used to assess the aesthetic quality of the soft tissue surrounding the implant restoration.

    Scale: 0 to 14.

    Interpretation: A higher score indicates a better and more aesthetically pleasing outcome.

  4. Pain Numeric Scale

    Time frame: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.

    Pain Numeric Rating Scale (NRS): This scale measures the patient's subjective experience of pain during the insertion of the final prosthesis.

    Scale: 0 ("no pain") to 10 ("worst pain imaginable").

    Interpretation: A higher score indicates a worse outcome, representing more severe pain.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: T2: At the one-month follow-up appointment.

    Plaque Index (PI): This index is used to quantify the amount of dental plaque present on the implant restoration.

    Scale: 0 to 3.

    Interpretation: A higher score indicates a worse outcome, corresponding to a greater accumulation of plaque.

Sponsors and collaborators

Lead sponsor

Amrita Institute of Medical Sciences & Research Center

Other

Registry information

Official study title

A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile and Evaluation of Peri-implant Soft Tissue; an In-vivo Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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