- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963884
Relate Tooth Alveolar Extraction Socket Anatomy to Alveolar Remodeling Rate
Study of Tooth Alveolar Extraction Socket Anatomy and Its Relation to Alveolar Post-extraction Changes
Study Overview
Status
Detailed 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)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Lisbon, Portugal, 1500-662
- Instituto de Implantologia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient that require a maxillary anterior extraction
- Sign Informed Consent
- Indication for a two-stage implant placement
Exclusion Criteria:
- Indication for immediate implants
- Indication for alveolar socket preservation or bone regeneration
- Indication for soft tissue graft
- Diabetes
- taking oral or intravenous biphosphonates
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Alveolar Socket Below Basal Bone
Tooth and the alveolar socket are positioned below basal bone.
Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation
|
Tooth from the maxillary anterior area extracted and alveolar socket remains intact
Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.
Other Names:
In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension
Other Names:
|
|
Alveolar Socket in Basal Bone (imbedded)
Tooth and alveolar socket are positioned in basal bone.
Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation
|
Tooth from the maxillary anterior area extracted and alveolar socket remains intact
Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.
Other Names:
In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension
Other Names:
|
|
Alveolar Socket Buccal to Basal Bone
Tooth and alveolar socket are positioned buccally in relation to maxillary basal bone.
Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation
|
Tooth from the maxillary anterior area extracted and alveolar socket remains intact
Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.
Other Names:
In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in alveolar ridge dimensions
Time Frame: From Tooth extraction (baseline T0) to T1 (6 month) to T2 (12 month)
|
report the change in alveolar extraction socket dimensions from tooth extraction to 1 year, measured in digital computer, from Cone-Beam originated images.
|
From Tooth extraction (baseline T0) to T1 (6 month) to T2 (12 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andre Chen, Msc, Implantology Institute
- Study Chair: Helena Francisco, Msc, Implantology Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- II-04
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