Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01533571 |
| Other study ID # |
Juodzbalys |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
February 7, 2012 |
| Last updated |
March 6, 2015 |
| Start date |
January 2014 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
March 2015 |
| Source |
Lithuanian University of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Lithuania: Bioethics Committee |
| Study type |
Interventional
|
Clinical 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.
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.
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:
1. Group I patients (n = 30) treated with immediate implant and GBR using xenogenic bone
graft material;
2. 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.
1. Soft tissue contour variations;
2. Vertical soft tissue deficiency;
3. The keratinized gingival (KG) width on the mid-buccal side of the socket;
4. Mesial and distal papillae appearance
5. Gingival tissue biotype;
6. Soft tissue quality;
7. The height of alveolar process;
8. Available bone beyond the apex of extraction socket;
9. Extraction socket labial plate vertical position;
10. Extraction socket facial bone thickness;
11. Presence of extraction socket bone lesions;
12. Intra-dental bone peak height (interproximal bone height);
13. The mesio-distal (M-D) distance between adjacent;
14. 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:
1. Bone in front to the implant width;
2. Bucco-lingual ridge width;
3. Vertical residual gap;
4. 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:
1. Preoperative picture of mouth area of patient, including smile line
2. Clinical preoperative picture of defect area (approximately 4 teeth in picture)
3. Preoperative orthopantomography and periapical X-ray
4. Extraction of the tooth
5. Socket measurements with caliper and probe
6. Operation area ready for implantation
7. Implant placement
8. Bone substitute application
9. Resorbable membrane application
10. Clinical situation right after surgery with the provisional crown
11. Clinical situation postoperative 1 week (if available)
12. Clinical situation postoperative 6 months without provisional crown (incisal edges and
frontal view projections)
13. Clinical situation postoperative 6 months with permanent crown (incisal edges and
frontal view projections)
14. Follow-up after 6 months periapical X-ray
15. Alveolar process measurements with caliper and probe
16. Clinical situation postoperative 1 year after treatment (incisal edges and frontal view
projections)
17. Follow-up after 1 year periapical X-ray
18. 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
1. Soft tissue contour variations (probe) No □ <2mm □ ≥2mm □
2. Soft tissue vertical deficiency (probe) No □ 1 to 2 mm □ >2 mm □
3. Soft tissue color and texture variations No □ Moderate □ Obvious □
4. Mesial papillae appearance Complete fill □ Partial fill □ None □
5. Distal papillae appearance Complete fill □ Partial fill □ None □
S index general rating and evaluation grade 100% 60-90% <50%
P index
1. Mesial interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
2. Distal interproximal bone height (periapical X-ray) <5 mm □ 5 to 7 mm □ >7 mm □
3. 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
1. Color and translucency No □ Moderate □ Obvious □
2. Labial convexity in the abutment/implant junction No □ <1 mm □ <2 mm □
3. Implant/crown incisal edge position No □ ±1mm □ ±2 mm □
4. Crown width/length ratio <0.85 □ 0.85 to 1.0 □ >1.0 □
5. 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____%.
