A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant
- Conditions
- Customized Healing AbutmentDental ImplantComposite ResinPeri-Implant Health
- Registration Number
- NCT07196293
- Lead Sponsor
- Amrita Institute of Medical Sciences & Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gingival Index (GI) 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) 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 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) 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 Outcome Measures
Name Time Method Plaque Index (PI) 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.
Trial Locations
- Locations (1)
Amrita School Of Dentistry
🇮🇳Kochi, Kerala, India
Amrita School Of Dentistry🇮🇳Kochi, Kerala, India