Composite Resin, Customized Healing Abutment, Dental Implant, Peri-Implant Health
Conditions
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.
Interventions
PROCEDURECustomized Healing Abutment - bulk fill composite
instead of standard healing abutments , customization was done using bulk fill composite
PROCEDUREcustomized healing abutments - Bis acryl composite materials
customized healing abutments with bis acryl composite material was used instead of standard healing abutments
Sponsors
Amrita Institute of Medical Sciences & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed