Immediate Implant Placement in the Esthetic Zone
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| First Received Date ICMJE | February 7, 2012 | ||||||||||||||||||||||||
| Last Updated Date | February 29, 2012 | ||||||||||||||||||||||||
| Start Date ICMJE | April 2012 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Complex Esthetic Index (CEI) [ Time Frame: One year ] [ Designated as safety issue: No ] CEI will be evaluated by two calibrated observers and mean will be calculated. Complex esthetic index is composed of three components: the soft tissue index (S), predictive index (P) and implant supported restoration index (R). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01533571 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Immediate Implant Placement in the Esthetic Zone | ||||||||||||||||||||||||
| Official Title ICMJE | Immediate Implant Placement After Tooth Extraction in the Esthetic Zone: Extraction Socket Morphology-Guided Treatment Modalities and Esthetic Outcome | ||||||||||||||||||||||||
| Brief Summary | This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate resorption and soft tissue recession following immediate implant placement in extraction sockets in the maxillary esthetic zone using different socket morphology-guided treatment modalities. Expected results of the study are:
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| Detailed Description | Aim of the study: to examine dimensional alveolar ridge alterations and prevent buccal plate resorption and soft tissue recession following immediate implant placement in extraction sockets in the maxillary esthetic zone using different socket morphology-guided treatment modalities. Objectives:
Methods Patients sampling:
Result analysis Size of the research: Sixty patients referred to an oral implantologist in Kaunas, Vilnius, Granada, Ankara cities that need immediate implants in the esthetic zone. There will be 2 groups of patients:
Expected result: After the study, we hope to have found the optimal materials and GBR procedures modalities for buccal plate resorption degree reduction, soft tissue recession and best esthetic result achievement. There will be possibilities to study socket morphology influence on final esthetic result achievement. Funds: Private sponsorship, companies sponsorship (Straumann and Botiss Dental). Detailed Protocol After patient selection there will be few steps in present study (you can press Ctrl-Enter and go directly to the selected step): Step 1. Clinical examination and documentation Conventional clinical examination will be done. Orthopantomograph and standardized periapical radiograph will be registered for every patient. Informed consent should be signed. Additionally an acrylic stent will be fabricated for each subject. This stent will be fixed on the incisal edges of the adjacent teeth taking into consideration planned acrylic temporary tooth space. The stent will provide three buccal/lingual pairs of consistent measurement points for each implant site located 4, 7, and 10 mm from the summit of the alveolar soft tissue. One aperture 1 will be above soft tissue margin. We should insert into aperture 1 cylinder with constant length until it contact most prominent implant transfer part. Then assistant should add acrylic or composite resin into aperture and fix cylinder strongly into template by this way. Thus we will have constant distance from point 1 to the implant collar (5 or 6mm according to the need). Step 2. Tooth extraction Following local anesthesia, the teeth should be gently extracted, using 15c blades, periotomes, elevators and forceps, minimizing any fractures of the socket walls. Sites are thoroughly degranulated for proper visualization and clinical assessment of the socket morphology. Step 3. Socket assessments and classification Below is an overview of extraction socket classification (Appendix 2 and Figure 1). As stated before, this classification is derived from present soft and hard tissue variables.
All linear measurements will be performed to the closest 1 mm with the use of a periodontal probe. All measurements will be done by two surgeons and mean will be calculated. Step 4. Dental implant placement. All implants should be placed in the optimal three dimensional position. Dental implant should be placed in the cingulum position (in line with adjacent teeth) and planned implant tooth incisal edge position should be in line with adjacent teeth incisal edge. In this ideal position, the implant collar should be 2 mm below the cementoenamel junction of the adjacent teeth apicocoronally or 3-4 mm bellow planned soft tissue margin, and at least 1.5 mm away from adjacent teeth mesiodistally. After placement of optimal dental implant the remaining gap between the implant and the surrounding bony walls should be at least 2 mm or should be need for GBR of buccal plate outside the socket. Step 5. Implant position and alveolar bone assessment:
Step 7. The provisional crown fixation. Individualized provisional acrylic crown will be fabricated before operation and will be adapted and fixed on temporary abutment after implant insertion if there is initial implant stability under 35 Ncm insertion torque. The provisional crown will be cemented with temporary cement. If the implant fails to achieve initial stability under 35 Ncm insertion torque, the provisional acrylic crown would be bonded to the neighboring teeth. In all cases, the provisional crowns are excluded from occlusion. After 6 months, the provisional restorations will be replaced by a permanent cemented or screw-retained zirconia crown. Step 8. Final prosthetic treatment After 6 months, the provisional restorations will be replaced by a permanent cemented zirconia crown fixed on zirconia abutment. Patients follow up: Patients will be rechecked two times: 6 months and 1 year after implant treatment. Step 10. Complex Esthetic Index (CEI) for anterior maxillary implant supported restorations This complex esthetic index is composed of three components: the soft tissue index (S), predictive index (P) and implant supported restoration index (R) (Appendix 1). Appendix 1. Clinical documentation sequence:
Appendix 2. Extraction socket soft and hard tissue assessments and socket types questionnaire Observer:_________________ Assessment series No □ Date: Cause for tooth loss: Patients name and family name: Gender: Male □ Female □ Tooth No: 15 14 13 12 11 21 22 23 24 25 Soft and hard tissues assessment Extraction socket types: Adequate Compromised Deficient Soft tissue Quantity Soft tissue contour variations No □ <2 mm □ ≥2 mm □ Soft tissue vertical deficiency (probe) No □ 1 to 2 mm □ >2 mm □ Keratinized gingival width (probe) >2 mm □ 1 to 2 mm □ <1 mm □ Mesial and distal papillae appearance (Nordland & Tarnow) I □ II □ III □ Soft tissue color, consistency, and contour Pink, firm and smooth □ Slightly red, soft sponge and uneven contour □ Red/Bluish, red, soft oedematous and boggy or craterlike soft tissue appearance □ Biotype of gingival tissue (probe) Thick □ Moderate □ Thin □ 2.0 mm □ ≥1.0 to <2.0 mm □ <1.0 mm □ Hard tissue Height of alveolar process (orthopantomograph) >10 mm □ >8 to ≤10 mm □ ≤8 mm □ Available bone beyond the apex of extraction socket (orthopantomograph) ≥4 mm □ ≥3 to <4 mm □ <3 mm □ Extraction socket labial plate vertical position; (probe) ≤3 mm □ >3 to <7 mm □ ≥7 mm □ Extraction socket facial bone thickness (caliper) ≥2 mm □ ≥1 to <2 mm □ <1 mm □ Presence of socket bone lesions No □ Yes □ Yes □ Mesial and distal intra-dental bone peak height (periapical X-ray) 3 to 4 mm □ ≥1 to <3 mm □ <1 mm □ Mesio-distal distance between adjacent teeth (probe) ≥7 mm □ >5 to <7 mm □ ≤5 mm □ The need for palatal angulation (diagnostic wax-up) <5° □ 5-30° □ >30° □ Extraction socket type: Appendix 3. Complex Esthetic Index (CEI) questionnaire Observer:_________________ Assessment series No □ Date: Patients name and family name: Index and parameters Rating and evaluation grades of parameters variations Adequate 20% Compromised 10% Deficient 0% S index
S index general rating and evaluation grade 100% 60-90% <50% P index
Implant apico-coronal position (probe) 1.5 to 3 mm □ >3 to5 mm □ >5 mm □ 5 Horizontal contour deficiency (probe) No □ 1 to 3 mm □ >3 mm □ P index general rating and evaluation grade 100% 60-90% <50% R index
R index general rating and evaluation grade 100% 60-90% <50% Gender: Male □ Female □ Tooth No: 15 14 13 12 11 21 22 23 24 25 Complex Esthetic Index: S¬____% P____% R____%. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Unspecified Atrophy of Edentulous Alveolar Ridge | ||||||||||||||||||||||||
| Intervention ICMJE | Procedure: Immediate implant placement with simultaneous bone grafting
Crown can be fixed on abutment if there is initial stability under 35 Ncm insertion torque. If insertion torque will be less, crown should be bond to neighboring teeth using composite material. Other Names:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||||||||||||||||||
| Estimated Completion Date | December 2013 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | United States, Lithuania, Spain, Turkey | ||||||||||||||||||||||||
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| NCT Number ICMJE | NCT01533571 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | Juodzbalys | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Povilas Daugela, Lithuanian University of Health Sciences | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Lithuanian University of Health Sciences | ||||||||||||||||||||||||
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| Investigators ICMJE |
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| Information Provided By | Lithuanian University of Health Sciences | ||||||||||||||||||||||||
| Verification Date | February 2012 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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