Influence of Abutment Angulation on Implant Failure in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides: RCT

NCT ID: NCT03243695

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-30

Brief Summary

patients with fractured teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured.

Detailed Description

A: General operative procedures:

The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.

If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.

The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.

A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.

The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.

The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.

The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.

The guide will be exported from the software and printed.

Intra operative procedures:

Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.

The remaining tooth will be extracted atraumatically using periotome for better bone preservation.

After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.

Surgical guide will be placed and checked for stability and drilling will be performed following instructions.

Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.

The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.

Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.

The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.

The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.

Conditions

Immediate Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Angled abutment

According to the allocation, the experimental group will receive an angled abutment on the immediately placed implant. A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)

Group Type: EXPERIMENTAL

Angled Abutment

Intervention Type: OTHER

virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated.

Straight abutment

According to the allocation, the control group will receive on the immediately placed implant a Straight zero degree abutment . A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)

Group Type: ACTIVE_COMPARATOR

straight abutment

Intervention Type: OTHER

virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated.

Interventions

Angled Abutment

virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated.

Intervention Type: OTHER

straight abutment

virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with teeth or remaining roots indicated for extraction in the esthetic zone and eligible for immediate implant placement Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan Presence of adequate mesio distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast Presence of adjacent natural teeth to the tooth/teeth to be extracted

Exclusion Criteria

• Presence of active signs or symptoms of acute infection in the tooth or the remaining root Heavy smokers (more than 2 packs per day) Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation) Severe overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Huda Fakhry Fouad

Assistant lecturer Prosthodontic department Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry

Giza, , Egypt

Countries

Egypt

References

Araújo, M.G. et al., 2005. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. Journal of clinical periodontology, 32(6), pp.645-52. Brosh, T., Pilo, R. & Sudai, D., 1998. The influence of abutment angulation on strains and stresses along the implant/bone interface: comparison between two experimental techniques. The Journal of prosthetic dentistry, 79(3), pp.328-34. Chrcanovic, B.R., Albrektsson, T. & Wennerberg, A., 2015. Tilted versus axially placed dental implants: a meta-analysis. Journal of dentistry, 43(2), pp.149-70. Del Fabbro, M. et al., 2015. Immediate loading of postextraction implants in the esthetic area: systematic review of the literature. Clinical implant dentistry and related research, 17(1), pp.52-70.

Reference Type: BACKGROUND

Other Identifiers

Prosth department

Identifier Type: -

Identifier Source: org_study_id