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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Gingival Index (GI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
customized healing abutment - bulk-fill flowable composite
Intervention: Customized Healing Abutment - bulk fill composite (Procedure)
standard titanium healing abutment
standard titanium healing abutments used
customized healing abutment - Protemp 4 (Bis-Acryl composite)
Intervention: customized healing abutments - Bis acryl composite materials (Procedure)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Plaque Index (PI)(T2: At the one-month follow-up appointment.)
Investigators
Bhavin Milind Patil
Principal Investigator
Amrita Institute of Medical Sciences & Research Center