Which type of implant placement provides better clinical outcome in patients?

Not yet recruiting

• Conditions: Absence of teeth in the upper jaw (maxilla)

• Registration Number: CTRI/2022/03/041078
• Lead Sponsor: International Team For Implantology

Brief Summary

Implant supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jaws. The concept of tilted implants is well documented in the dental literature and high implant survival and success rates for rehabilitation of edentulous arches have been reported.Even though the concept of tilted implants is documented in the literature, the majority of the studies performed evaluated the success and survival rates of this technique without a proper control group.Therefore, in this study, besides the comparison between the two different reconstruction workflows , the patients will be randomized to receive axially or tilted implants. Overall, the expected outcome of this study might help clinicians in their decision making-process when rehabilitating cases of atrophic maxilla.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-31
• Last Update Posted: 2022-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients should be of minimum 18 years to be included in the study.
• Patient with edentulous maxilla.
• Presence of natural teeth or dentures in the mandibular arch.
• Presence of adequate primary stability during implant placement.
• Adequate bone volume to place at least 4 implants with a standard diameter & at least 6 mm in length.
• Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar).
• Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region to place an implant of a regular diameter with a minimum length of 8 mm.
• Presence of healed maxillary edentulous ridge (at least 3 months post extraction).

Exclusion Criteria

• Self reported history of bruxism.
• Uncontrolled diabetes (HbA1c>7.5 mg/dl).
• History of irradiation in the head and neck region.
• Inability to comply with annual implant maintenance follow up.
• Ridge profile not allowing the placement of a fixed prostheses.
• Presence of systemic disease that contraindicates implant placement.
• Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the evaluation of prosthetic complications of CAD-CAM fabricated and denture-conversion prosthesis using modified USPHS scores at 3 months of function.	3 months

Secondary Outcome Measures

Name	Time	Method
Survival rates:	To evaluate implant survival rates of tilted and axially placed implants at 1 year, 3 years and 5 years
Prosthetic Level:	Incidence of chipping of the final prostheses, fracture of abutment/ crown or frame work, fracture of veneering ceramic, occlusal roughness, loss of retention (loosening of crown or abutment screw) and the contour of restoration will be evaluated at 4 weeks after insertion of final prosthesis and at 1 year, 3 years and 5 years after function for final prosthesis using the Modified USPS scores.
Implant Level:	Fracture of screw and implant will be evaluated at 4 weeks after insertion of final prosthesis (BL1) and at 1 year, 3 years and 5 years.
PROMS:	-VAS scores based questionnaires about maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at insertion of interim prosthesis ( Visit 3; prior to implant insertion,) at baseline and 3 months after use of provisional prostheses. Similarly VAS scores will be evaluated at the time of insertion of final prostheses (BL1) and at 1, 3 and 5 years after function.
Operator based preferences:	VAS scores based questionnaires for operator based preferences with respect to the ease of surgery and insertion of CAD-CAM fabricated provisional prostheses and denture conversion prostheses will be assessed after the insertion of provisional prostheses.
Clinical outcomes:	The following clinical outcomes will be evaluated at baseline after a functional period 3 months for provisional prostheses; and after insertion of final prosthesis (BL1) and after a functional period of 1, 3 and 5 years by using a dental probe
Radiographic Outcomes	Crestal bone loss

Trial Locations

Locations (1)

M.A. Rangoonwala College of Dental Sciences and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

M.A. Rangoonwala College of Dental Sciences and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Mohit kheur

Principal investigator

mkheur@gmail.com