CompletedNot Applicable

Response of Hard and Soft Tissue Around the Dental Implant to 2-Piece Abutment Vs Conventional Restorative Protocols

India10 participantsStarted 2019-03-13

Plain-language summary

The goal of the study is to determine whether using a two-piece definitive abutment, as opposed to a traditional two-stage healing abutment connection, will reduce the loss of crestal bone surrounding the implant and improve soft tissue adaption. With the use of a manual periodontal probe, it will be recorded at four locations per implant. In order to prevent its removal during healing, an abutment base of the definitive restorative abutment will be positioned during implant surgery. Therefore, there is no departure from the standard course of treatment. An implant and crown will be used to replace a lost tooth, which will benefit the patients. Benefit to society: more predictable and enhanced functional and aesthetic treatment outcomes. Benefit to Scientific Advancement: This concept will be beneficial in maintaining the peri-implant soft tissue and bone levels. Changes in interproximal bone levels will be measured in standardized periapical digital radiographs (x-rays) once a month, which is usually not associated with any complications. The number of visits to the hospital: On the day of implant placement, 12th-week Impression Visit, 16th-week Prosthesis Placement, 20th-week 1st Month post prosthesis, follow up, 28th-week 3rd-month post prosthesis follow-up, 40th-week 6th-month post prosthesis follow-up, 64th-week 1-year follow-up after placing the definitive restoration. On every visit, radiographs will be taken. Patients should maintain regular oral hygiene to prevent future bone loss. No one else shall be privy to participants' details. Implant treatment for the participant is free. The participant will give consent for any advisable and necessary dental procedures, medications, or anaesthetics to be administered by the attending dentist or his supervised staff for diagnostic purposes or for implant placement. Also give consent to make radiographic and photographic records; these records may also include study models, x-rays, and blood studies. If implants fail, then they will be retreated free of charge. Participants understood and acknowledged that they agreed to be part of this clinical study, will keep up with the follow-up appointments, and if they want, they can choose to drop out of the study anytime on the course of study. That there is no force or influence to participate, that he/she can take enough time to decide whether to participate, and that he/she can ask any doubts to the PI at any point in time.

Who can participate

Age range

18 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: * Adequate width and height of bone for the placement of appropriate size implant(s). * Well-healed edentulous sites with a minimum of 2 mm of soft tissue thickness. * Patients willing to participate by giving informed consent. * Patients agreeing to attend the planned follow-up visits. Exclusion Criteria: * Medically compromised patients where surgery was contraindicated. * Patients with poor oral hygiene and/or suffering from periodontal disease. * Patients with insufficient quantity/quality of bone. * Patient with edentulous sites with a lack of attached gingiva. * Patients with edentulous sites with insufficient prosthetic space. * Patients with a history of parafunctional occlusal habits. * Tobacco or alcohol use or drug dependency.

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

Crestal Bone levels

Timeframe: I year follow up

Trial details

NCT IDNCT06818890

SponsorHasan Sarfaraz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-12

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