Extracting Own TeethPhase 1NCT06164626
Evaluation of Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Biomaterial Grafting
A Phase 1 study testing Extraction, low level laser therapy and Plenum® OSShp and Plenum® Guide in people with Extracting Own Teeth and Bone Substitutes, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Extracting Own Teeth, Bone Substitutes
- What is being tested?
- Extraction, low level laser therapy and Plenum® OSShp and Plenum® Guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2023to 20 Nov 2024
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All genders,
- Aged over 18 years,
- Without comorbidities,
- Present satisfactory oral hygiene,
- Present a condition of loss of first or second permanent molar.
Who cannot join
- Habitual use of analgesic and anti-inflammatory medication for other comorbidities,
- Present allergies to the proposed drug protocol,
- In neurological/psychiatric treatment,
- Presence of teeth with lesions to be treated in the same hemiarch of the tooth to be removed,
- Current smoking habit,
- Pregnant or breast-feeding,
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- Presenting photosensitivity disorders,
- With the presence of neoplasia in the oral region,
- Patients with operative complications whose surgical time exceeds 90 minutes
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Uniersidade Nove de Julho
São Paulo, São Paulo, 03155-000
Sandra Kalil Bussadori, PhD, 551126339000, sandra.skb@gmail.com
About this study
Official title: Evaluation of Alveolar Bone Preservation After Early Molar Extraction Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial: Clinical, Randomized, Triple-blind Study.
Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. The bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients age from 18 years, with an indication for extraction associated or not with treatment with an 808 nm infrared laser. . Materials and methods: 60 patients age from 18 years will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with graft of biomaterial), Exo+Biomat+Laser (biomaterial extraction and grafting and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the socket immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 buccal, occlusal and lingual/palatal points), will receive irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, the operator who will apply the laser and the patient will be blind to the device used and the patient will not know whether or not they received the biomaterial. Analysis: computed tomography and intraoral scanning performed pre-surgery and 4 months after surgery; to assess bone volume by measurements of the height and width of the socket in each group, as well as trabecular bone and the interdental space of the teeth lateral to the missing element. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t-test or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, will be two-tailed and the significance level adopted will be α = 0.05.
Read the detailed description
Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. Bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients aged 18 years and over, with indications for extraction associated or not with 808 nm infrared treatment. laser. . Materials and methods: 60 patients aged 18 years and over will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with bone graft). biomaterial), Exo+Biomat+Laser (extraction and grafting of biomaterials and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the socket immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 points buccal, occlusal and lingual/palatal), will receive irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, the operator who will apply the laser and the patient will not have knowledge of the device used and will not know whether or not they received the biomaterial. Analysis: computed tomography performed preoperatively and 4 months after surgery; evaluate the bone volume by measuring the height and width of the socket in each group, as well as the trabecular bone and the interdental space of the teeth lateral to the missing element, and fractal analysis evaluating the volume and density of the formed bone. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t test or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, will be two-tailed and the significance level adopted will be α = 0.05.
- Conditions
- Extracting Own Teeth, Bone Substitutes
- Being tested
- Extraction, low level laser therapy, Plenum® OSShp and Plenum® Guide
- Keywords
- Bone regeneration, photobiomodulation, scaffold biomaterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtractionProcedure or surgery
extraction: in all groups, extraction will be performed
low level laser therapyRadiation
extraction: in all groups, extraction will be performed Treatment with low-intensity infrared 808 nm laser therapy will be applied in 2 stages: one in the immediate postoperative period and 10 days after surgery.
Plenum® OSShp and Plenum® GuideBiological
extraction: in all groups, extraction will be performed Immediately after tooth extraction, the biomaterials Plenum® OSShp and Plenum® Guide (Brazil) will be added to the dental socket, serving as a bone substitute and maintaining alveolar dimensions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1 | Experimental | 15 patients who will only have their first teeth or second molars extracted. Receives: Procedure: Extraction |
| Experimental:Group 2 | Experimental | 15 patients who will have only their first or second molars extracted and will receive infrared laser treatment Receives: Procedure: Extraction; Radiation: low level laser therapy |
| Experimental: Group 3 | Experimental | 15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial Receives: Procedure: Extraction; Biological: Plenum® OSShp and Plenum® Guide |
| Experimental:Group 4 | Experimental | 15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial and infrared laser treatment Receives: Procedure: Extraction; Radiation: low level laser therapy; Biological: Plenum® OSShp and Plenum® Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical intervention phase
The computed tomography examination will be carried out in two moments, with the tooth before extraction and after 4 months of surgery and the measurements chosen for the dimensional measurement of the alveolar process will refer to the buccolingual thickness of the alveolus. In the orthoradial cut, the limits of the socket will be delimited based on the apex of the tooth to the maximum height of the bone crests. In the most central position, the vertical measurement will be taken and 3 buccolingual cuts will be made, proportional to each other according to the measured vertical measurement; and in each apical, middle and cervical third, measurements will be taken regarding the horizontal dimensions of the alveolus. For the fractal analysis, the area of interest encompassing the dental socket will be delimited and the Image J program, which is in the public domain, will be used to calculate the fractal dimension.
Measured: Baseline, pre surgical, 4 months
Secondary outcomes (1)
Interdental distance
n the computed tomography, the horizontal distance will be measured with the limit in the mesial and distal bone crystals of the alveolus at two moments, pre-surgery with the tooth still in place and 4 months after extraction, to verify the maintenance of the interdental space.
Measured: Baseline, pre surgical, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start10 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Extracting Own TeethStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164626
- Sponsor's protocol ID
- Vanessa Dalapria
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The participants' transcribed information will be transcribed into a database replacing the individuals' names with registration numbers from the initial assessment form. The datasets (Excel spreadsheet) generated from this protocol will be available from the corresponding author (Sandra Kalil Bussadorisandra.skb@gmail.com) upon reasonable request. However, reuse of this data will not be permitted by anyone other than the author of this article.
Publications
Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
PubMed 15015736De Marchi RJ, Hugo FN, Hilgert JB, Padilha DM. Association between oral health status and nutritional status in south Brazilian independent-living older people. Nutrition. 2008 Jun;24(6):546-53. doi: 10.1016/j.nut.2008.01.054.
PubMed 18455655Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Rezaie M, Ghapanchi J, Haghnegahdar A, Khojastehpour L, Khorshidi H, Heidari H. A Radiographic Evaluation of Missing of Permanent First Molars in a Group of Iranian Children and Adults: A Retrospective Study. Int J Dent. 2018 Apr 1;2018:5253965. doi: 10.1155/2018/5253965. eCollection 2018.
PubMed 29808093Saber AM, Altoukhi DH, Horaib MF, El-Housseiny AA, Alamoudi NM, Sabbagh HJ. Consequences of early extraction of compromised first permanent molar: a systematic review. BMC Oral Health. 2018 Apr 5;18(1):59. doi: 10.1186/s12903-018-0516-4.
PubMed 29622000Alkhadra T. A Systematic Review of the Consequences of Early Extraction of First Permanent First Molar in Different Mixed Dentition Stages. J Int Soc Prev Community Dent. 2017 Sep-Oct;7(5):223-226. doi: 10.4103/jispcd.JISPCD_222_17. Epub 2017 Sep 18.
PubMed 29026692Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.
PubMed 28000281Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
PubMed 18672985Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x.
PubMed 19522974Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
PubMed 15882225Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
PubMed 19929956Osburn RC. Preservation of the alveolar ridge: a simplified technique for retaining teeth beneath removable appliances. J Indiana State Dent Assoc. 1974 Jan-Feb;53(1):8-11. No abstract available.
PubMed 4523604PELTIER LF. The use of plaster of Paris to fill defects in bone. Clin Orthop. 1961;21:1-31. No abstract available.
PubMed 14485018Artzi Z, Nemcovsky CE. The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol. 1998 Sep;69(9):1062-7. doi: 10.1902/jop.1998.69.9.1062.
PubMed 9776036Faour O, Dimitriou R, Cousins CA, Giannoudis PV. The use of bone graft substitutes in large cancellous voids: any specific needs? Injury. 2011 Sep;42 Suppl 2:S87-90. doi: 10.1016/j.injury.2011.06.020. Epub 2011 Jul 2.
PubMed 21723553
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alveolar Bone Preservation After Early Molar Extraction Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial: Clinical, Randomized, Triple-blind Study.
- ClinicalTrials.gov ID
- NCT06164626
- Acronym / sponsor ID
- Vanessa Dalapria
- Conditions
- Extracting Own Teeth, Bone Substitutes
- Keywords
- Bone regeneration, photobiomodulation, scaffold biomaterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- 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.
Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. The bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients age from 18 years, with an indication for extraction associated or not with treatment with an 808 nm infrared laser. . Materials and methods: 60 patients age from 18 years will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with graft of biomaterial), Exo+Biomat+Laser (biomaterial extraction and grafting and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the socket immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 buccal, occlusal and lingual/palatal points), will receive irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, the operator who will apply the laser and the patient will be blind to the device used and the patient will not know whether or not they received the biomaterial. Analysis: computed tomography and intraoral scanning performed pre-surgery and 4 months after surgery; to assess bone volume by measurements of the height and width of the socket in each group, as well as trabecular bone and the interdental space of the teeth lateral to the missing element. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t-test or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, will be two-tailed and the significance level adopted will be α = 0.05.
Detailed description
Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. Bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients aged 18 years and over, with indications for extraction associated or not with 808 nm infrared treatment. laser. . Materials and methods: 60 patients aged 18 years and over will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with bone graft). biomaterial), Exo+Biomat+Laser (extraction and grafting of biomaterials and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the socket immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 points buccal, occlusal and lingual/palatal), will receive irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, the operator who will apply the laser and the patient will not have knowledge of the device used and will not know whether or not they received the biomaterial. Analysis: computed tomography performed preoperatively and 4 months after surgery; evaluate the bone volume by measuring the height and width of the socket in each group, as well as the trabecular bone and the interdental space of the teeth lateral to the missing element, and fractal analysis evaluating the volume and density of the formed bone. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t test or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, will be two-tailed and the significance level adopted will be α = 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 | Experimental | Procedure: Extraction15 patients who will only have their first teeth or second molars extracted. |
| Experimental:Group 2 | Experimental | Procedure: Extraction, Radiation: low level laser therapy15 patients who will have only their first or second molars extracted and will receive infrared laser treatment |
| Experimental: Group 3 | Experimental | Procedure: Extraction, Biological: Plenum® OSShp and Plenum® Guide15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial |
| Experimental:Group 4 | Experimental | Procedure: Extraction, Radiation: low level laser therapy, Biological: Plenum® OSShp and Plenum® Guide15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial and infrared laser treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All genders,
- Aged over 18 years,
- Without comorbidities,
- Present satisfactory oral hygiene,
- Present a condition of loss of first or second permanent molar.
Key exclusion criteria (9 listed)
- Habitual use of analgesic and anti-inflammatory medication for other comorbidities,
- Present allergies to the proposed drug protocol,
- In neurological/psychiatric treatment,
- Presence of teeth with lesions to be treated in the same hemiarch of the tooth to be removed,
- Current smoking habit,
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 |
|---|---|---|
| Extractionextraction: in all groups, extraction will be performed | Procedure or surgery | Experimental: Group 1, Experimental: Group 3, Experimental:Group 2, Experimental:Group 4 |
| low level laser therapyextraction: in all groups, extraction will be performed Treatment with low-intensity infrared 808 nm laser therapy will be applied in 2 stages: one in the immediate postoperative period and 10 days after surgery. | Radiation | Experimental:Group 2, Experimental:Group 4 |
| Plenum® OSShp and Plenum® Guideextraction: in all groups, extraction will be performed Immediately after tooth extraction, the biomaterials Plenum® OSShp and Plenum® Guide (Brazil) will be added to the dental socket, serving as a bone substitute and maintaining alveolar dimensions. | Biological | Experimental: Group 3, Experimental:Group 4 |
Primary outcome
Surgical intervention phase
Time frame: Baseline, pre surgical, 4 months
The computed tomography examination will be carried out in two moments, with the tooth before extraction and after 4 months of surgery and the measurements chosen for the dimensional measurement of the alveolar process will refer to the buccolingual thickness of the alveolus. In the orthoradial cut, the limits of the socket will be delimited based on the apex of the tooth to the maximum height of the bone crests. In the most central position, the vertical measurement will be taken and 3 buccolingual cuts will be made, proportional to each other according to the measured vertical measurement; and in each apical, middle and cervical third, measurements will be taken regarding the horizontal dimensions of the alveolus. For the fractal analysis, the area of interest encompassing the dental socket will be delimited and the Image J program, which is in the public domain, will be used to calculate the fractal dimension.
1 secondary outcome
Interdental distance
Time frame: Baseline, pre surgical, 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 15015736Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
- Background: PubMed 18455655De Marchi RJ, Hugo FN, Hilgert JB, Padilha DM. Association between oral health status and nutritional status in south Brazilian independent-living older people. Nutrition. 2008 Jun;24(6):546-53. doi: 10.1016/j.nut.2008.01.054.
- Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Background: PubMed 29808093Rezaie M, Ghapanchi J, Haghnegahdar A, Khojastehpour L, Khorshidi H, Heidari H. A Radiographic Evaluation of Missing of Permanent First Molars in a Group of Iranian Children and Adults: A Retrospective Study. Int J Dent. 2018 Apr 1;2018:5253965. doi: 10.1155/2018/5253965. eCollection 2018.
- Background: PubMed 29622000Saber AM, Altoukhi DH, Horaib MF, El-Housseiny AA, Alamoudi NM, Sabbagh HJ. Consequences of early extraction of compromised first permanent molar: a systematic review. BMC Oral Health. 2018 Apr 5;18(1):59. doi: 10.1186/s12903-018-0516-4.
- Background: PubMed 29026692Alkhadra T. A Systematic Review of the Consequences of Early Extraction of First Permanent First Molar in Different Mixed Dentition Stages. J Int Soc Prev Community Dent. 2017 Sep-Oct;7(5):223-226. doi: 10.4103/jispcd.JISPCD_222_17. Epub 2017 Sep 18.
- Background: PubMed 28000281Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.
- Background: PubMed 18672985Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
- Background: PubMed 19522974Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x.
- Background: PubMed 15882225Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
- Background: PubMed 19929956Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
- Background: PubMed 4523604Osburn RC. Preservation of the alveolar ridge: a simplified technique for retaining teeth beneath removable appliances. J Indiana State Dent Assoc. 1974 Jan-Feb;53(1):8-11. No abstract available.
- Individual participant dataSharing planned: Yes. The participants' transcribed information will be transcribed into a database replacing the individuals' names with registration numbers from the initial assessment form. The datasets (Excel spreadsheet) generated from this protocol will be available from the corresponding author (Sandra Kalil Bussadorisandra.skb@gmail.com) upon reasonable request. However, reuse of this data will not be permitted by anyone other than the author of this article.
Related trials for Extracting Own Teeth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extraction, low level laser therapy and Plenum® OSShp and Plenum® Guide in people with Extracting Own Teeth and Bone Substitutes, run by University of Nove de Julho at 1 site in Brazil.
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 5 inclusion and 9 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 14 Dec 2023. 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 Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sandra Kalil Bussadori, PhD (551132283400, sandra.skb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical intervention phase (time frame: Baseline, pre surgical, 4 months). 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 NCT06164626, which also lists 73 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 14 Dec 2023.