Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT01963884 |
| Other study ID # |
II-04 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
October 12, 2013 |
| Last updated |
October 12, 2013 |
| Start date |
January 2014 |
| Est. completion date |
August 2016 |
Study information
| Verified date |
October 2013 |
| Source |
Instituto de Implantologia |
| Contact |
André Chen, Msc |
| Phone |
00351919774343 |
| Email |
tsouchen[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
Portugal: Ethics Committee for Clinical Research |
| Study type |
Observational
|
Clinical Trial Summary
In patients that are going to be subjected to a tooth extraction in the anterior maxillary
(from canine to canine) does the position of the intact alveolar socket related to maxillary
basal bone interferes with the rate of resorption and remodeling process of the alveolar
ridge ?
Description:
We intend to demonstrate the physiologic process of the post-extraction socket and we
hypothesized that the position of the socket in relation to basal bone, may project the
remodeling process through three different equations.
A- tooth-periodontal apparatus is placed buccally of the basal bone - Equation 1
Anatomy Features- only 1-2 mm of lamina dura on the buccal part, 1-2mm of lamina dura on the
palatal, plus basal bone.
Physiologic features - when the alveolar apparatus remodels, after tooth extraction, the
amount that we project for resorption is : 1-2 mm of buccal lamina dura, the buccal-palatal
dimension of the tooth that was extracted plus the 1-2 mm of palatal lamina dura.
At 6 month we hypothesized that 3 mm of trabecular bone may be present, so we may account
for 2-3 mm more.
Due to conical anatomy of anterior teeth, the amount of trabecular bone will be more
pronounced in the coronal area than in apical area, so we also account for that variation.
At this stage we project that the amount of ridge dimension will be :
buccal soft tissue (BST) + trabecular alveolar bone (ATB) + basal bone (BB) + palatal soft
tissue (PST) Equation at 6 Month = (BST + ATB + PST).
But at 1 year the trabecular bone may be absent, so we project that the equation will be :
buccal soft tissue+basal bone+palatal soft tissue. Equation at 1 Year (BST + BB + PST)
at the end, ridge dimension will be : palatal basal bone plus soft tissue buccally and
palatally.
Numbers for Buccal placed alveolus apparatus :
At Pre-extraction appointment (estimate) :
BST+ Lamina Dura Buccal + tooth buccal lingual dimension + palatal lamina dura + BB + PST
(3mm + 1mm + X+ 1mm + Y + 3mm) = 8 mm + X (a or b or c) + Y (a or b or c)
X = For Anterior Teeth= 3 measures = coronal (Xa) + middle (Xb) + apical (Xc) Y- Basal bone
is genetically predetermined and vary from person to person but geometrically can have two
measures one middle (Ya) and one apical (Yb)
Note : the buccal-lingual dimensions vary from coronal to apical (either in the tooth root
and in basal bone), so we hypothesize that the subtraction from pre-extraction values to
post-extraction will more pronounced in coronal area than in the apical area.
At 6 month post-extraction :
BST+ ATB (varies coronal (a) , middle (b) , apical (c)) + BB + PST (3mm + ATB (a or b or c)
+ Y + 3mm) = 6 mm + ATB (a or b or c) + Y (a or b)
At 1 Year post-extraction
BST + BB + PST (3mm + X1 + 3mm) = 6 mm + Y (a or b )
Example For Central Incisor :
Before Extraction (estimate)
at coronal part pre-extraction : 3 + 1 + 10 (Xa) + 1 + 3 (Ya) + 3 = 21 mm at middle part
pre-extraction : 3 + 1 + 5 (Xb) + 1 + 5 (Yb) + 3 = 18 mm at apical part pre-extraction : 3 +
1 + 2 (Xc) + 1 + 8 (Yc) + 3 = 18 mm
After Extraction 6 month (estimate)
at coronal part post-extraction : 3 + 3 (ATBa) + 3 + 3 = 12 mm at middle part
post-extraction : 3 + 2 (ATBb) + 5 + 3 = 13 mm at apical part post-extraction : 3 + 1 (ATBc)
+ 8 + 3 = 15 mm
Variation expected (estimate) from Pre-extraction to 6 month post-extraction in buccally
placed alveolar socket will be (estimate):
At coronal part ⨺ (variation) = 9 mm (43% reduction) at middle part ⨺ (variation) = 5 mm
(28% reduction) at middle part ⨺ (variation) = 3 mm (17% reduction)
After Extraction 1 Year (estimate)
at coronal part post-extraction : 3 + 3 + 3 = 9 mm at middle part post-extraction : 3 + 5 +
3 = 11 mm at apical part post-extraction : 3 + 8 + 3 = 14 mm
Variation expected (estimate) from Pre-extraction to 1 year post extraction in buccally
placed alveolar socket will be:
At coronal part ⨺ (variation) = 12 mm (57% reduction) at middle part ⨺ (variation) = 7 mm
(39% reduction) at middle part ⨺ (variation) = 4 mm (22% reduction)
B- Tooth-periodontal apparatus is inferior of the basal bone (true socket) - Equation 2
Anatomy features- only 1-2 mm of lamina dura on the buccal and palatal part, no basal bone
palatal, the basal bone is superior to the alveolar process.
Physiologic features - when the alveolar apparatus remodels after tooth extraction we
project that the amount of resorption will be 1-2 mm of buccal lamina dura, the
buccal-palatal dimension of the tooth that was extracted, plus the 1-2 mm of palatal lamina
dura.
At 6 month, we hypothesized that 3 mm of trabecular bone may be present, so we may account
for 2-3 mm more. At this stage the amount of ridge dimension will be composed by :
buccal soft tissue (BST) + trabecular alveolar bone (ATB) + palatal soft tissue (PST),
(BST+ATB+PST).
note : lamina dura disappears, but because periosteum has to adhere to bone an outer
cortical forms that surrounds remaining trabecular bone.
Numbers for Inferior placed alveolus apparatus :
At Pre-extraction appointment (estimate) :
BST+ Lamina Dura Buccal + tooth buccal-lingual dimension + palatal lamina dura + PST
Equation = (3mm + 1mm + X+ 1mm + 3mm) = 8 mm + X (a or b or c)
X = For Anterior Teeth = 3 measures = coronal (Xa) + middle (Xb) + apical (Xc)
note : the buccal-lingual dimensions vary from coronal to apical (either in the tooth root
and in basal bone), so we hypothesize that the subtraction from pre-extraction values to
post-extraction will more pronounced in coronal area than in the apical area
At 6 month post-extraction (estimate) :
BST+ ATB (varies coronal (a) , middle (b) , apical (c) + PST Equation = (3mm + ATB (a or b
or c) + 3mm) = 6 mm + ATB (a or b or c)
At 1 Year post-extraction (estimate)
BST + ATB (a or b or c) + PST (3mm + X1 + 3mm) = 6 mm + ATB (a or b or c)
Example For Central Incisor :
Before Extraction (estimate)
at coronal part pre-extraction : 3 + 1 + 10 (Xa) + 1 + 3 = 18 mm at middle part
pre-extraction : 3 + 1 + 5 (Xb) + 1 + 3 = 13 mm at apical part pre-extraction : 3 + 1 + 2
(Xc) + 1 + 3 = 10 mm
After Extraction 6 month (estimate)
at coronal part post-extraction : 3 + 3 (ATBa) + 3 = 9 mm at middle part post-extraction : 3
+ 2 (ATBb) + 3 = 8 mm at apical part post-extraction : 3 + 1 (ATBc) + 3 = 7 mm
Variation expected (projected) from Pre-extraction to 6 month post-extraction in inferior
placed alveolar socket will be (estimate):
At coronal part ⨺ (variation) = 9 mm (43% reduction) at middle part ⨺ (variation) = 5 mm
(28% reduction) at middle part ⨺ (variation) = 3 mm (17% reduction)
After Extraction 1 Year (estimate)
at coronal part post-extraction : 3 + 2 + 3 = 8 mm at middle part post-extraction : 3 + 2 +
3 = 8 mm at apical part post-extraction : 3 + 2 + 3 = 8 mm
Variation expected (estimate) from Pre-extraction to 1 year post-extraction in inferior
placed alveolar socket will be:
at coronal part ⨺ (variation) = 10 mm (57% reduction) at middle part ⨺ (variation) = 5 mm
(38% reduction) at middle part ⨺ (variation) = 2 mm (20% reduction)
C- tooth-periodontal apparatus is in (imbedded) the basal bone - Equation 3
Anatomy features- only 1-2 mm of lamina dura on the buccal part, 1-2mm of lamina dura on the
palatal plus basal bone on the buccal and on the lingual part.
Physiologic features - when the alveolar apparatus remodels after tooth extraction, we
project that the amount of resorption will be 1-2 mm of buccal lamina dura the
buccal-palatal dimension of the tooth that was extracted plus the 1-2 mm of palatal lamina
dura.
At 6 month, we hypothesized that 3 mm of trabecular bone may be present so we may account
for 2-3mm more. At this stage the amount of ridge dimension will be composed by:
buccal soft tissue (BST) + Buccal basal bone (BBB) + trabecular alveolar bone (ATB)+ palatal
basal bone (LBB)+ palatal soft tissue (PST), Equation = (BST+BBB+ATB+PBB+PST)
Numbers for Imbedded alveolus apparatus :
At Pre-extraction appointment (estimate):
BST+ BBB (Y1 a or b or c) + Lamina Dura Buccal + tooth buccal lingual dimension (X a or b or
c) + palatal lamina dura + PBB (Y2 a or b or c or d) + PST (3mm + 1mm + X+ 1mm + 3mm) = 8 mm
+Y1 + X (a or b or c or d) +Y2
X = For Anterior teeth = 3 measures = coronal (Xa) + middle (Xb) + apical (Xc)
Y1- Buccal Basal bone is genetically predetermined and vary from person to person
geometrically 3 measures coronal (a) middle (b) and apical (c)
Y2- Palatal Basal bone (PBB) is genetically predetermined and vary from person to person
geometrically 3 measures coronal (a) middle (b) and apical (c)
note : the buccal-lingual dimensions vary from coronal to apical (either in the tooth root
and in basal bone), so we hypothesize that the subtraction from pre-extraction values to
post-extraction will more pronounced in coronal area than in the apical area
At 6 month post-extraction (estimate):
BST+ BBB (Y1 a or b or c) + ATB (varies coronal (a) , middle (b) , apical (c)) + PBB (Y2 a
or b or c) + PST (3mm + Y1+ ATB (a or b or c) + Y2 + 3mm) = 6 mm + ATB (a or b or c)
At 1 Year post-extraction (estimate)
BST+ BBB (Y1 a or b or c) + ATB (a or b or c) + PBB (Y2 a or b or c) + PST (3mm + X1 + 3mm)
= 6 mm + Y1 (a or b or c) + ATB (a or b or c) + + PBB (Y2 a or b or c)
Example For Central Incisor :
Before Extraction (estimate)
at coronal part pre-extraction : 3 + 3 + 1 + 10 (Xa) + 1 + 3 + 3 = 24 mm at middle part
pre-extraction : 3 + 5 + 1+ 5 (Xb) + 1 + 5 + 3 = 23 mm at apical part pre-extraction : 3 + 8
+ 1 + 2 (Xc) + 1 + 8 + 3 = 26 mm
After Extraction 6 month (estimate)
at coronal part post-extraction : 3 + 3 + 10 (ATBa) + 3 + 3 = 22 mm at middle part
post-extraction : 3 + 5 + 5 (ATBb) + 5 + 3 = 21 mm at apical part post-extraction : 3 + 8 +
2 (ATBc) + 8 + 3 = 24 mm
Variation expected (estimate) from Pre-extraction to 6 month post-extraction in imbedded
placed alveolar socket will be:
At coronal part ⨺ (variation) = 2 mm (8% reduction) at middle part ⨺ (variation) = 2 mm (8%
reduction) at middle part ⨺ (variation) = 2 mm (8% reduction)
After (estimate) Extraction 1 Year
at coronal part post-extraction : 3 + 3? + 10 + 3 ?+ 3 = 14 mm at middle part
post-extraction : 3 + 5?+ 5 + 5? + 3 = 18 mm at apical part post-extraction : 3 + 8 ? + 2 +
8? + 3 = 8 mm
Variation expected (estimate) from Pre-extraction to 1 year post-extraction in imbedded
placed alveolar socket will be:
At coronal part ⨺ (variation) = 2 mm (8% reduction) at middle part ⨺ (variation) = 2 mm (8%
reduction) at middle part ⨺ (variation) = 2 mm (8% reduction)
