Clinical trial NCT03230500: Computer Guided Versus Free Hand Immediate Implant Placement
Official title: Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: computer guided
immediate implant
patient satisfaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.

Detailed description: General operative procedures:

Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).

Patients of both groups will be subjected to:

Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.

Intraoperative procedure:

3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining root or tooth will be performed. For a traumatic extraction, gentle application of a periotome mesio-distally along with slight rotational movement. After extraction, intact labial and palatal socket walls will be checked using periodontal probe for immediate implant placement. For the test group, the computer aided surgical guide will be checked for adaptability and any interference will be removed. After that implant drilling and placement will be performed using the surgical guide. For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. For both groups implant primary stability will be checked by application of 35 Ncm2 force using torque wrench After that, the final abutment will be screwed in its position and the temporary crown will be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be checked for any functional contact in maximum intercuspation and lateral movement. Any contact with the opposing should be removed and the patient will be instructed to avoid eating or incising on the temporary crown for at least two weeks. Seven days later patients will be recalled for inspection and taking postoperative photos, six months thereafter, the patient will receive a definitive crown.

Eligibility criteria: Inclusion Criteria:

Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.

Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.

Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.

Presence of adjacent teeth to the tooth or remaining root to be extracted.

Exclusion Criteria:

Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.

Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.

Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis...)

Primary outcomes:
measure: Patient satisfaction
timeFrame: 0-6 months
Secondary outcomes:
measure: Early implant failure
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Safaa hussein
Study officials:
References:
citation: Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.
citation: Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
citation: Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.