Loss of Teeth Due to ExtractionNCT01963884
Relate Tooth Alveolar Extraction Socket Anatomy to Alveolar Remodeling Rate
An observational study of Loss of Teeth Due to Extraction and Alveolar Bone Loss, run by Implantology Institute at 1 site in Portugal.
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 ? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loss of Teeth Due to Extraction, Alveolar Bone Loss, Bone Resorption
- What is being tested?
- Tooth Extraction, Cone-Beam technology evaluation and Measure Alveolar Socket Remodeling
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to Aug 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that require at least on tooth extraction of the upper anterior jaw (maxilla) canine, central incisor and lateral incisor.
Who may be able to join
- Patient that require a maxillary anterior extraction
- Sign Informed Consent
- Indication for a two-stage implant placement
Who cannot join
- Indication for immediate implants
- Indication for alveolar socket preservation or bone regeneration
- Indication for soft tissue graft
- Diabetes
- taking oral or intravenous biphosphonates
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto de Implantologia
Lisbon, Lisbon District, 1500-662
joana velez, joana.velez@institutodeimplantologia.com
Andre Chen, Msc
About this study
Official title: Study of Tooth Alveolar Extraction Socket Anatomy and Its Relation to Alveolar Post-extraction Changes
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 ?
Read the 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)
- Being tested
- Tooth Extraction, Cone-Beam technology evaluation, Measure Alveolar Socket Remodeling
- Keywords
- Extraction Sockets, Ridge dimensions, Dental Alveolar Anatomy, Dental Implants, Bone Physiology
- Medical subject headings
- Alveolar Bone Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth ExtractionProcedure or surgery
Tooth from the maxillary anterior area extracted and alveolar socket remains intact
Cone-Beam technology evaluationRadiation
Also called Computerized Tomography, Imaging exams
Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.
Measure Alveolar Socket RemodelingOther
Also called Digital Measurements
In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Tooth Extraction; Radiation: Cone-Beam technology evaluation; Other: Measure Alveolar Socket Remodeling | |
| 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 Receives: Procedure: Tooth Extraction; Radiation: Cone-Beam technology evaluation; Other: Measure Alveolar Socket Remodeling | |
| 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 Receives: Procedure: Tooth Extraction; Radiation: Cone-Beam technology evaluation; Other: Measure Alveolar Socket Remodeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alveolar ridge dimensions
report the change in alveolar extraction socket dimensions from tooth extraction to 1 year, measured in digital computer, from Cone-Beam originated images.
Measured: From Tooth extraction (baseline T0) to T1 (6 month) to T2 (12 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Teeth Due to ExtractionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
- Investigators
- Andre Chen, Msc, Principal investigator, Implantology InstituteJoão Caramês, Phd, Study director, Implantology InstituteHelena Francisco, Msc, Study chair, Implantology InstituteElena Cervino, Msc, Study chair, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963884
- Sponsor's protocol ID
- II-04
- Status last verified
- Oct 2013
- First submitted
- 12 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tooth Alveolar Extraction Socket Anatomy and Its Relation to Alveolar Post-extraction Changes
- ClinicalTrials.gov ID
- NCT01963884
- Acronym / sponsor ID
- II-04
- Keywords
- Extraction Sockets, Ridge dimensions, Dental Alveolar Anatomy, Dental Implants, Bone Physiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 16 Oct 2013 (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.
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 ?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alveolar Socket Below Basal Bone | – | Procedure: Tooth Extraction, Radiation: Cone-Beam technology evaluation, Other: Measure Alveolar Socket RemodelingTooth and the alveolar socket are positioned below basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation |
| Alveolar Socket in Basal Bone (imbedded) | – | Procedure: Tooth Extraction, Radiation: Cone-Beam technology evaluation, Other: Measure Alveolar Socket RemodelingTooth and alveolar socket are positioned in basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation |
| Alveolar Socket Buccal to Basal Bone | – | Procedure: Tooth Extraction, Radiation: Cone-Beam technology evaluation, Other: Measure Alveolar Socket RemodelingTooth and alveolar socket are positioned buccally in relation to maxillary basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that require at least on tooth extraction of the upper anterior jaw (maxilla) canine, central incisor and lateral incisor.
Key inclusion criteria (3 listed)
- Patient that require a maxillary anterior extraction
- Sign Informed Consent
- Indication for a two-stage implant placement
Key exclusion criteria (5 listed)
- Indication for immediate implants
- Indication for alveolar socket preservation or bone regeneration
- Indication for soft tissue graft
- Diabetes
- taking oral or intravenous biphosphonates
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 |
|---|---|---|
| Tooth ExtractionTooth from the maxillary anterior area extracted and alveolar socket remains intact | Procedure or surgery | Alveolar Socket Below Basal Bone, Alveolar Socket Buccal to Basal Bone, Alveolar Socket in Basal Bone (imbedded) |
| Cone-Beam technology evaluationAlso: Computerized Tomography, Imaging examsPatient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation. | Radiation | Alveolar Socket Below Basal Bone, Alveolar Socket Buccal to Basal Bone, Alveolar Socket in Basal Bone (imbedded) |
| Measure Alveolar Socket RemodelingAlso: Digital MeasurementsIn a computer, cone-beam images are superimposed to measure total the amount of ridge dimension | Other | Alveolar Socket Below Basal Bone, Alveolar Socket Buccal to Basal Bone, Alveolar Socket in Basal Bone (imbedded) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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.
Andre Chen, Msc principal investigator
Implantology Institute
João Caramês, Phd study director
Implantology Institute
Helena Francisco, Msc study chair
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loss of Teeth Due to Extraction and Alveolar Bone Loss, run by Implantology Institute at 1 site in Portugal.
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 3 inclusion and 5 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
Contact André Chen, Msc (00351919774343, tsouchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alveolar ridge dimensions (time frame: From Tooth extraction (baseline T0) to T1 (6 month) to T2 (12 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2013.