Unspecified Atrophy of Edentulous Alveolar RidgeNCT01533571
Immediate Implant Placement in the Esthetic Zone
A study testing Immediate implant placement with simultaneous bone grafting in people with Unspecified Atrophy of Edentulous Alveolar Ridge, run by Lithuanian University of Health Sciences at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Immediate implant placement with simultaneous bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General health satisfactory
- Single-tooth replacement in the maxillary anterior segments
- Extraction socket Type I and Type II (Juodzbalys et al.)
- Non-adjacent implant sites and prosthetic restorations
- Patient will not wear any kind of removable prosthesis over the treatment area;
- Availability of complete clinical records.
Who cannot join
- Uncontrolled diabetes
- Immunodeficiency diseases
- Heavy smokers (more than 10 cigarettes a day)
- Untreated periodontal disease.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Immediate Implant Placement After Tooth Extraction in the Esthetic Zone: Extraction Socket Morphology-Guided Treatment Modalities and Esthetic Outcome
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:
- 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.
Read the 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:
- To evaluate extraction socket buccal plate resorption rate among patients groups with immediate implant placement simultaneously with guided bone regeneration (GBR) methods using different types of bone graft materials.
- To evaluate esthetic outcome using Complex Esthetic Index (CEI) (Appendix 3) and correlate this to the initial buccal plate thickness and soft tissue biotype assessed during immediate implant placement simultaneously with GBR.
- To recommend the most appropriate method for prevention of buccal plate resorption, soft tissue recession and esthetic result achievement following immediate implant placement in extraction sockets in the maxillary esthetic zone.
Methods
Patients sampling:
- Selection of patients with sufficient extraction sockets for immediate dental implant installation with guided bone regeneration (GBR) procedure.
- Assessment of the extraction socket should be done using classification of extraction socket based upon soft and hard tissue components before the treatment (Appendix 2).
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:
- Group I patients (n = 30) treated with immediate implant and GBR using xenogenic bone graft material;
- Group II patients (n = 30) treated with immediate implant and GBR using allogenic bone graft material.
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.
- Soft tissue contour variations;
- Vertical soft tissue deficiency;
- The keratinized gingival (KG) width on the mid-buccal side of the socket;
- Mesial and distal papillae appearance
- Gingival tissue biotype;
- Soft tissue quality;
- The height of alveolar process;
- Available bone beyond the apex of extraction socket;
- Extraction socket labial plate vertical position;
- Extraction socket facial bone thickness;
- Presence of extraction socket bone lesions;
- Intra-dental bone peak height (interproximal bone height);
- The mesio-distal (M-D) distance between adjacent;
- Palatal angulation.
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:
- Bone in front to the implant width;
- Bucco-lingual ridge width;
- Vertical residual gap;
- Implant apico-coronal position. Step 6. The remaining defects augmentation based on the proposed scheme. Flapless surgery will be applied consequently GBR application place will be inside the socket. The remaining defects and dehiscences after implant placement will be filled up, using two types of bone graft materials: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane and Group II - processed human allograft + resorbable natural soft tissue membrane. In future we will call Group II control group. Resorbable membrane should be condensed on bone graft without pressure and fixed by provisional crown. Conventional medicament treatment including Chlorhexidine 0.2% oral rinses twice daily for 2 weeks will be applied.
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:
- Preoperative picture of mouth area of patient, including smile line
- Clinical preoperative picture of defect area (approximately 4 teeth in picture)
- Preoperative orthopantomography and periapical X-ray
- Extraction of the tooth
- Socket measurements with caliper and probe
- Operation area ready for implantation
- Implant placement
- Bone substitute application
- Resorbable membrane application
- Clinical situation right after surgery with the provisional crown
- Clinical situation postoperative 1 week (if available)
- Clinical situation postoperative 6 months without provisional crown (incisal edges and frontal view projections)
- Clinical situation postoperative 6 months with permanent crown (incisal edges and frontal view projections)
- Follow-up after 6 months periapical X-ray
- Alveolar process measurements with caliper and probe
- Clinical situation postoperative 1 year after treatment (incisal edges and frontal view projections)
- Follow-up after 1 year periapical X-ray
- Alveolar process measurements with caliper and probe
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
- Soft tissue contour variations (probe) No □ <2mm □ ≥2mm □
- Soft tissue vertical deficiency (probe) No □ 1 to 2 mm □ >2 mm □
- Soft tissue color and texture variations No □ Moderate □ Obvious □
- Mesial papillae appearance Complete fill □ Partial fill □ None □
- Distal papillae appearance Complete fill □ Partial fill □ None □
S index general rating and evaluation grade 100% 60-90% <50%
P index
- Mesial interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
- Distal interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
- Gingival tissue biotype (probe) >2 mm □ 1 to 2 mm □ <1 mm □ 4
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
- Color and translucency No □ Moderate □ Obvious □
- Labial convexity in the abutment/implant junction No □ <1 mm □ <2 mm □
- Implant/crown incisal edge position No □ ±1mm □ ±2 mm □
- Crown width/length ratio <0.85 □ 0.85 to 1.0 □ >1.0 □
- Surface roughness and ridges No □ Moderate □ Obvious □
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____%.
- Being tested
- Immediate implant placement with simultaneous bone grafting
- Keywords
- Guided Bone Regeneration, Dental Implant, Alveolar Ridge Augmentation, Socket graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement with simultaneous bone graftingProcedure or surgery
Also called Cerabone, Jason membrane, Maxgarft, Straumann Bone level implant
- Flapless surgery is used for surgical implant installation.
- Implant is placed in the cingulum position of adjacent teeth incisal edge.
- After placement of optimal 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.
- Two types of bone graft materials will be applied for two groups of patients: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane; Group II - processed human allograft + resorbable natural soft tissue membrane .
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant + xenogenic graft | Active comparator | Treatment with immediate implant and GBR using xenogenic bone graft material Receives: Procedure: Immediate implant placement with simultaneous bone grafting |
| Immediate implant + allogenic graft | Active comparator | Treatment with immediate implant and GBR using allogenic bone graft material. Receives: Procedure: Immediate implant placement with simultaneous bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complex Esthetic Index (CEI)
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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJan 2014
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Unspecified Atrophy of Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Universidad de Granada, University of Michigan
- Responsible party
- Principal investigator, Povilas Daugela, Lithuanian University of Health Sciences
- Investigators
- Gintaras Juodzbalys, Professor, Study chair, Lithuanian University of Health Sciences (Lithuania)Hom-Lay Wang, Professor, Study chair, University of MichiganPablo Galindo-Moreno, Professor, Principal investigator, University of Granada (Spain)Tolga F Tozum, Professor, Principal investigator, Hacettepe University (Turkey)Povilas Daugela, Dr., Principal investigator, Lithuanian University of Health Sciences (Lithuania)Algirdas Puisys, Dr., Principal investigator, Lithuanian University of Health Sciences (Lithuania)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533571
- Sponsor's protocol ID
- Juodzbalys
- Status last verified
- Mar 2015
- First submitted
- 7 Feb 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Juodzbalys G, Wang HL. Socket morphology-based treatment for implant esthetics: a pilot study. Int J Oral Maxillofac Implants. 2010 Sep-Oct;25(5):970-8.
PubMed 20862411Juodzbalys G, Wang HL. Esthetic index for anterior maxillary implant-supported restorations. J Periodontol. 2010 Jan;81(1):34-42. doi: 10.1902/jop.2009.090385.
PubMed 20059415Juodzbalys G, Sakavicius D, Wang HL. Classification of extraction sockets based upon soft and hard tissue components. J Periodontol. 2008 Mar;79(3):413-24. doi: 10.1902/jop.2008.070397.
PubMed 18315423Juodzbalys G, Bojarskas S, Kubilius R, Wang HL. Using the support immersion endoscope for socket assessment. J Periodontol. 2008 Jan;79(1):64-71. doi: 10.1902/jop.2008.070253.
PubMed 18166094Juodzbalys G, Wang HL. Soft and hard tissue assessment of immediate implant placement: a case series. Clin Oral Implants Res. 2007 Apr;18(2):237-43. doi: 10.1111/j.1600-0501.2006.01312.x.
PubMed 17348889Nordland WP, Tarnow DP. A classification system for loss of papillary height. J Periodontol. 1998 Oct;69(10):1124-6. doi: 10.1902/jop.1998.69.10.1124.
PubMed 9802711
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement After Tooth Extraction in the Esthetic Zone: Extraction Socket Morphology-Guided Treatment Modalities and Esthetic Outcome
- ClinicalTrials.gov ID
- NCT01533571
- Acronym / sponsor ID
- Juodzbalys
- Keywords
- Guided Bone Regeneration, Dental Implant, Alveolar Ridge Augmentation, Socket graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Hacettepe University, Universidad de Granada, University of Michigan
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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:
- To evaluate extraction socket buccal plate resorption rate among patients groups with immediate implant placement simultaneously with guided bone regeneration (GBR) methods using different types of bone graft materials.
- To evaluate esthetic outcome using Complex Esthetic Index (CEI) (Appendix 3) and correlate this to the initial buccal plate thickness and soft tissue biotype assessed during immediate implant placement simultaneously with GBR.
- To recommend the most appropriate method for prevention of buccal plate resorption, soft tissue recession and esthetic result achievement following immediate implant placement in extraction sockets in the maxillary esthetic zone.
Methods
Patients sampling:
- Selection of patients with sufficient extraction sockets for immediate dental implant installation with guided bone regeneration (GBR) procedure.
- Assessment of the extraction socket should be done using classification of extraction socket based upon soft and hard tissue components before the treatment (Appendix 2).
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:
- Group I patients (n = 30) treated with immediate implant and GBR using xenogenic bone graft material;
- Group II patients (n = 30) treated with immediate implant and GBR using allogenic bone graft material.
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.
- Soft tissue contour variations;
- Vertical soft tissue deficiency;
- The keratinized gingival (KG) width on the mid-buccal side of the socket;
- Mesial and distal papillae appearance
- Gingival tissue biotype;
- Soft tissue quality;
- The height of alveolar process;
- Available bone beyond the apex of extraction socket;
- Extraction socket labial plate vertical position;
- Extraction socket facial bone thickness;
- Presence of extraction socket bone lesions;
- Intra-dental bone peak height (interproximal bone height);
- The mesio-distal (M-D) distance between adjacent;
- Palatal angulation.
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:
- Bone in front to the implant width;
- Bucco-lingual ridge width;
- Vertical residual gap;
- Implant apico-coronal position. Step 6. The remaining defects augmentation based on the proposed scheme. Flapless surgery will be applied consequently GBR application place will be inside the socket. The remaining defects and dehiscences after implant placement will be filled up, using two types of bone graft materials: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane and Group II - processed human allograft + resorbable natural soft tissue membrane. In future we will call Group II control group. Resorbable membrane should be condensed on bone graft without pressure and fixed by provisional crown. Conventional medicament treatment including Chlorhexidine 0.2% oral rinses twice daily for 2 weeks will be applied.
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:
- Preoperative picture of mouth area of patient, including smile line
- Clinical preoperative picture of defect area (approximately 4 teeth in picture)
- Preoperative orthopantomography and periapical X-ray
- Extraction of the tooth
- Socket measurements with caliper and probe
- Operation area ready for implantation
- Implant placement
- Bone substitute application
- Resorbable membrane application
- Clinical situation right after surgery with the provisional crown
- Clinical situation postoperative 1 week (if available)
- Clinical situation postoperative 6 months without provisional crown (incisal edges and frontal view projections)
- Clinical situation postoperative 6 months with permanent crown (incisal edges and frontal view projections)
- Follow-up after 6 months periapical X-ray
- Alveolar process measurements with caliper and probe
- Clinical situation postoperative 1 year after treatment (incisal edges and frontal view projections)
- Follow-up after 1 year periapical X-ray
- Alveolar process measurements with caliper and probe
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
- Soft tissue contour variations (probe) No □ <2mm □ ≥2mm □
- Soft tissue vertical deficiency (probe) No □ 1 to 2 mm □ >2 mm □
- Soft tissue color and texture variations No □ Moderate □ Obvious □
- Mesial papillae appearance Complete fill □ Partial fill □ None □
- Distal papillae appearance Complete fill □ Partial fill □ None □
S index general rating and evaluation grade 100% 60-90% <50%
P index
- Mesial interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
- Distal interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
- Gingival tissue biotype (probe) >2 mm □ 1 to 2 mm □ <1 mm □ 4
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
- Color and translucency No □ Moderate □ Obvious □
- Labial convexity in the abutment/implant junction No □ <1 mm □ <2 mm □
- Implant/crown incisal edge position No □ ±1mm □ ±2 mm □
- Crown width/length ratio <0.85 □ 0.85 to 1.0 □ >1.0 □
- Surface roughness and ridges No □ Moderate □ Obvious □
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____%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant + xenogenic graft | Active comparator | Procedure: Immediate implant placement with simultaneous bone graftingTreatment with immediate implant and GBR using xenogenic bone graft material |
| Immediate implant + allogenic graft | Active comparator | Procedure: Immediate implant placement with simultaneous bone graftingTreatment with immediate implant and GBR using allogenic bone graft material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- General health satisfactory
- Single-tooth replacement in the maxillary anterior segments
- Extraction socket Type I and Type II (Juodzbalys et al.)
- Non-adjacent implant sites and prosthetic restorations
- Patient will not wear any kind of removable prosthesis over the treatment area;
Key exclusion criteria (4 listed)
- Uncontrolled diabetes
- Immunodeficiency diseases
- Heavy smokers (more than 10 cigarettes a day)
- Untreated periodontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implant placement with simultaneous bone graftingAlso: Cerabone, Jason membrane, Maxgarft, Straumann Bone level implant* Flapless surgery is used for surgical implant installation. * Implant is placed in the cingulum position of adjacent teeth incisal edge. * After placement of optimal 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. * Two types of bone graft materials will be applied for two groups of patients: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane; Group II - processed human allograft + resorbable natural soft tissue membrane . 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. | Procedure or surgery | Immediate implant + allogenic graft, Immediate implant + xenogenic graft |
Primary outcome
Complex Esthetic Index (CEI)
Time frame: One year
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Background: PubMed 20862411Juodzbalys G, Wang HL. Socket morphology-based treatment for implant esthetics: a pilot study. Int J Oral Maxillofac Implants. 2010 Sep-Oct;25(5):970-8.
- Background: PubMed 20059415Juodzbalys G, Wang HL. Esthetic index for anterior maxillary implant-supported restorations. J Periodontol. 2010 Jan;81(1):34-42. doi: 10.1902/jop.2009.090385.
- Background: PubMed 18315423Juodzbalys G, Sakavicius D, Wang HL. Classification of extraction sockets based upon soft and hard tissue components. J Periodontol. 2008 Mar;79(3):413-24. doi: 10.1902/jop.2008.070397.
- Background: PubMed 18166094Juodzbalys G, Bojarskas S, Kubilius R, Wang HL. Using the support immersion endoscope for socket assessment. J Periodontol. 2008 Jan;79(1):64-71. doi: 10.1902/jop.2008.070253.
- Background: PubMed 17348889Juodzbalys G, Wang HL. Soft and hard tissue assessment of immediate implant placement: a case series. Clin Oral Implants Res. 2007 Apr;18(2):237-43. doi: 10.1111/j.1600-0501.2006.01312.x.
- Background: PubMed 9802711Nordland WP, Tarnow DP. A classification system for loss of papillary height. J Periodontol. 1998 Oct;69(10):1124-6. doi: 10.1902/jop.1998.69.10.1124.
- Journal of Oral \& Maxillofacial Research (JOMR)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gintaras Juodzbalys, Professor study chair
Lithuanian University of Health Sciences (Lithuania)
Hom-Lay Wang, Professor study chair
University of Michigan
Pablo Galindo-Moreno, Professor principal investigator
University of Granada (Spain)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement with simultaneous bone grafting in people with Unspecified Atrophy of Edentulous Alveolar Ridge, run by Lithuanian University of Health Sciences at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Lithuania, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complex Esthetic Index (CEI) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533571, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.