A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Ging… (NCT07196293) | Clinical Trial Compass
CompletedNot Applicable
A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant
India30 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gingival Index (GI)
Timeframe: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
2
Probing depth (PI)
Timeframe: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
3
Pink Esthetic Score (PES)
Timeframe: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
4
Pain Numeric Scale
Timeframe: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Trial details
NCT IDNCT07196293
SponsorAmrita Institute of Medical Sciences & Research Center