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

NCT07196293 | Completed

• 1 other identifier: ECASM-AIMS-2023-356
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Customized Healing Abutment; Dental Implant; Composite Resin; Peri-Implant Health

Outcome Measures

Primary Outcomes (4)

• Gingival Index (GI)

  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.

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

• Probing depth (PI)

  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.

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

• Pink Esthetic Score (PES)

  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.

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

• Pain Numeric Scale

  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.

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

Secondary Outcomes (1)

• Plaque Index (PI)

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

Study Arms (3)

standard titanium healing abutment

NO INTERVENTION

standard titanium healing abutments used

customized healing abutment - bulk-fill flowable composite

ACTIVE COMPARATOR

Procedure: Customized Healing Abutment - bulk fill composite

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

ACTIVE COMPARATOR

Procedure: customized healing abutments - Bis acryl composite materials

Interventions

Customized Healing Abutment - bulk fill composite PROCEDURE

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

customized healing abutment - bulk-fill flowable composite

customized healing abutments - Bis acryl composite materials PROCEDURE

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

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

Eligibility Criteria

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

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amrita Institute of Medical Sciences & Research Center: lead

Study Sites (1)

Amrita School Of Dentistry

Kochi, Kerala, 682041, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 29, 2025
• Study Start: September 1, 2023
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

IN (1)