Clinical and radiographic evaluation of short implants placed in the posterior mandible: A 2-year prospective cohort split-mouth study
- Conditions
- Tooth loss in posterior mandible
- Registration Number
- DRKS00004611
- Lead Sponsor
- Dentium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
1.Ability to understand the nature of the study and related procedures.
2.Written informed consent obtained according to the international guidelines and local law regulations.
3.The subject must be in the age between 18 and 70 years.
4.The subject must be systemically healthy and have good compliance.
5.The subject must have stable occlusal relationship with no pronounced parafunction such as bruxism.
6.The subject must be missing contralaterally the lower bicuspids or the second bicuspid and the first lower molar, and in need of bilateral implant-supported restorations in the posterior mandible.
7.The implant site must be free from infection and/or extraction remnants.
8.The subjects must have sufficient bone volume and density i.e. an osseous architecture in the implant region enough to accommodate implants of Ø 4 mm and a sufficient amount of bone for placing two implants with a length of at least 7 mm on one side of the posterior mandible and with a length of at least 10 mm on the contralateral side.
9.The osseous structure must allow for primary stability of the placed implant, i.e. final tightening torque of 35-45 Ncm.
1.Alcohol or drug abuse as noted in patient records or in patient history.
2.Smoking
3.Health conditions the do not allow for surgical procedures.
4.Reason to believe that the treatment might have a negative effect on the subject’s general situation (psychiatric conditions), as noted in patient records or in patient history.
5.The patient has an infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoietic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e., uncontrolled diabetes), pregnancy, local (i.e. tumors, ulcers, etc.) or other contraindications for dental surgery as noted in patient records or in patient history.
6.The subject is not able to give his/her informed consent to participate.
7.The need of bone augmentation.
8.Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiotherapy.
9.Severe bruxism or other destructive disease.
10.Immediate implant placement (e.g. placement of the implant immediately after tooth extraction).
11.Intake of a medication that is known to interfere with the objectives of the study and/or is contraindication of the surgical procedure within 2 weeks prior to entry into the study.
12.Intake of investigational drugs less than 30 days prior to entry into the study.
13.Female patients who are pregnant or breast feeding, or female patients of reproductive potential not employing an effective method of birth control (postmenopausal state at least since 2 years, surgically sterile, hysterectomy or effective contraceptive method until delivery of the final prosthetic restoration.
In female patients with a reproductive potential, implant placement will only be performed if a negative urine pregnancy test result dated 3-14 days prior to implantation is documented. Women have to be advised that they must not become pregnant until delivery of the final restorations has taken place.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to compare the mean marginal bone resorption between short implants (7mm) and regular-length implants (=10mm) after 1 and 2 years. The mean marginal bone resorption will be evaluated by a review of standardized digital periapical radiographs. The distance from the implant shoulder to the first radiographic observable bone-to-implant contact at implant insertion (mean of mesial and distal measurements) will be subtracted from the distance from the implant shoulder to the first radiographic observable bone-to-implant contact after 1 and 2 years, respectively.
- Secondary Outcome Measures
Name Time Method The secondary objectives are:<br>1-Compare several clinical parameters between short- and regular-length implants after 1 and 2 years. The parameters include but not limited to periimplant bleeding on probing, probing depth, clinical attachment level.<br>2-Evaluate the success of short implants in relation to the crown-to-root ratio.<br>