Tooth ExtractionNCT04346706
Immediate Implant Placement in Fresh Extraction Sockets and Delayed Implants in Healed Sockets.
A study testing Extraction and Implant insertion (test) in people with Tooth Extraction and Dental Implantation, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The purpose of this prospective clinical study was to compare in delayed and immediately placed implants, the marginal vertical bone loss at 4 sides of the implant (buccal, palatal, mesial and distal), as well as the buccal and palatal bone thickness reduction at 3 months after loading. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Dental Implantation, Bone Remodeling
- What is being tested?
- Extraction and Implant insertion (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Feb 2018to 25 Nov 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old, compliant (willing to show up to all their follow-up visits), and able to read, understand and sign an informed consent. All patients were to have good oral hygiene levels (full mouth plaque scores (FMPS) <15-20%, and full mouth bleeding index (FMBI) <15-20%), requiring implant insertion in a maxillary premolar site either immediately or in a healed "pristine bone".
Who cannot join
- Presence of major contraindications to implant surgery, patients that had received head and neck radiation for cancer treatment, immunosuppressed or immunocompromised patients, uncontrolled diabetes, pregnant or breast-feeding woman, untreated periodontitis and/or poor oral hygiene and motivation, presence of buccal dehiscence, and finally previous bone grafting or ridge preservation in the studied area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Evaluation of Marginal Bone Level, Buccal and Palatal Plate Thickness Alteration, and Implant Stability After Placement in Healed Ridges and Fresh Extraction Sockets: A 6 Months Prospective Study.
The purpose of this prospective clinical study was to compare in delayed and immediately placed implants, the marginal vertical bone loss at 4 sides of the implant (buccal, palatal, mesial and distal), as well as the buccal and palatal bone thickness reduction at 3 months after loading.
Read the detailed description
Twenty-four patients were consecutively selected and enrolled in this study based on the aforementioned exclusion and inclusion criteria. Clinical examination was done by a different clinician than the operator, and according to the treatment indication, patients were allocated to the delayed implant placement group (Control), or the immediate implant placement group (Test). Thus, 15 implants were placed in healed extraction sites and immediately temporized (Control group), and 15 implants were placed in immediate extraction sites with immediate temporization (Test group).
Provisional acrylic crowns were prepared. All patients were placed on a prophylactic antibiotic regimen, starting one day prior to surgery as they were asked to take amoxicillin 500 mg; three times a day for 10 days or clindamycin 300 mg twice daily for 10 days for penicillin-allergic patients.
For the test group, tooth extractions were carried out atraumatically using periotomes. In both groups, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm.
Temporary abutments were connected to the implants and torqued at 20 Ncm, and then temporary crowns were cemented on top of the abutments after checking and reducing occlusion to non-existent in both centric and lateral excursions.
- Conditions
- Tooth Extraction, Dental Implantation, Bone Remodeling
- Being tested
- Extraction and Implant insertion (test), Implant insertion (control)
- Keywords
- Dental implantation, Immediate dental implant loading, Marginal bone remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction and Implant insertion (test)Device
The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated. Tooth extractions were carried out atraumatically using periotomes. Implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ, at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.
Absorbable interrupted 4.0 sutures were used for flap closure.
Implant insertion (control)Device
The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ. This was done at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.
Absorbable interrupted 4.0 sutures were used for flap closure.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implantation | Experimental | Tooth extraction, immediate insertion of an implant with immediate temporization Receives: Device: Extraction and Implant insertion (test) |
| Delayed implantation | Experimental | Implant inserted in a healed socket with immediate temporization Receives: Device: Implant insertion (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of marginal vertical bone level at 6 months
Marginal vertical bone level changes at 4 sides of the implant (buccal, palatal, mesial and distal) on Cone Beam Computed Tomography (CBCT) images
Measured: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Change from baseline of bone plate thickness at 6 months
Buccal and palatal bone thickness at 4 levels : 0 mm, 2 mm, 4 mm and 6 mm from the implant platform on CBCT images
Measured: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Secondary outcomes (2)
Change from baseline of implant stability quotient at 3 months
Measurements of implant stability quotient (ISQ) following implant insertion
Measured: Following procedure at day 0 (implant insertion) and 3 months (post-implantation)
Record of insertion torque
Insertion torque value at implant placement
Measured: Following procedure at day 0 (implant insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start10 Feb 2018
- Primary completion20 Jul 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Tooth 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada BOU ABBOUD NAAMAN, Saint-Joseph University
- Investigators
- Nada Naaman, PhD, Study director, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346706
- Sponsor's protocol ID
- FMD124
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient characteristics. Outcome measures
Publications
Penarrocha-Diago M, Demarchi CL, Maestre-Ferrin L, Carrillo C, Penarrocha-Oltra D, Penarrocha-Diago MA. A retrospective comparison of 1,022 implants: immediate versus nonimmediate. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):421-7.
PubMed 22442783Kim JK, Yoon HJ. Clinical and radiographic outcomes of immediate and delayed placement of dental implants in molar and premolar regions. Clin Implant Dent Relat Res. 2017 Aug;19(4):703-709. doi: 10.1111/cid.12496. Epub 2017 May 18.
PubMed 28517552Atieh MA, Alsabeeha NH, Duncan WJ, de Silva RK, Cullinan MP, Schwass D, Payne AG. Immediate single implant restorations in mandibular molar extraction sockets: a controlled clinical trial. Clin Oral Implants Res. 2013 May;24(5):484-96. doi: 10.1111/j.1600-0501.2011.02415.x. Epub 2012 Jan 26.
PubMed 22276690Mello CC, Lemos CAA, Verri FR, Dos Santos DM, Goiato MC, Pellizzer EP. Immediate implant placement into fresh extraction sockets versus delayed implants into healed sockets: A systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2017 Sep;46(9):1162-1177. doi: 10.1016/j.ijom.2017.03.016. Epub 2017 May 3.
PubMed 28478869Lindeboom JA, Tjiook Y, Kroon FH. Immediate placement of implants in periapical infected sites: a prospective randomized study in 50 patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Jun;101(6):705-10. doi: 10.1016/j.tripleo.2005.08.022. Epub 2006 Mar 22.
PubMed 16731387Rowan M, Lee D, Pi-Anfruns J, Shiffler P, Aghaloo T, Moy PK. Mechanical versus biological stability of immediate and delayed implant placement using resonance frequency analysis. J Oral Maxillofac Surg. 2015 Feb;73(2):253-7. doi: 10.1016/j.joms.2014.09.024. Epub 2014 Oct 13.
PubMed 25579008Esposito M, Zucchelli G, Cannizzaro G, Checchi L, Barausse C, Trullenque-Eriksson A, Felice P. Immediate, immediate-delayed (6 weeks) and delayed (4 months) post-extractive single implants: 1-year post-loading data from a randomised controlled trial. Eur J Oral Implantol. 2017;10(1):11-26.
PubMed 28327692Berberi AN, Sabbagh JM, Aboushelib MN, Noujeim ZF, Salameh ZA. A 5-year comparison of marginal bone level following immediate loading of single-tooth implants placed in healed alveolar ridges and extraction sockets in the maxilla. Front Physiol. 2014 Jan 31;5:29. doi: 10.3389/fphys.2014.00029. eCollection 2014.
PubMed 24550840Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x.
PubMed 22897683Ostman PO, Hellman M, Sennerby L. Ten years later. Results from a prospective single-centre clinical study on 121 oxidized (TiUnite) Branemark implants in 46 patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):852-60. doi: 10.1111/j.1708-8208.2012.00453.x. Epub 2012 May 29.
PubMed 22642261Romeo E, Lops D, Margutti E, Ghisolfi M, Chiapasco M, Vogel G. Long-term survival and success of oral implants in the treatment of full and partial arches: a 7-year prospective study with the ITI dental implant system. Int J Oral Maxillofac Implants. 2004 Mar-Apr;19(2):247-59.
PubMed 15101597Covani U, Chiappe G, Bosco M, Orlando B, Quaranta A, Barone A. A 10-year evaluation of implants placed in fresh extraction sockets: a prospective cohort study. J Periodontol. 2012 Oct;83(10):1226-34. doi: 10.1902/jop.2012.110583. Epub 2012 Jan 5.
PubMed 22220768Fugazzotto PA. Implant placement at the time of mandibular molar extraction: description of technique and preliminary results of 341 cases. J Periodontol. 2008 Apr;79(4):737-47. doi: 10.1902/jop.2008.070293.
PubMed 18380569Gher ME, Quintero G, Assad D, Monaco E, Richardson AC. Bone grafting and guided bone regeneration for immediate dental implants in humans. J Periodontol. 1994 Sep;65(9):881-91. doi: 10.1902/jop.1994.65.9.881.
PubMed 7990026Schwartz-Arad D, Chaushu G. Placement of implants into fresh extraction sites: 4 to 7 years retrospective evaluation of 95 immediate implants. J Periodontol. 1997 Nov;68(11):1110-6. doi: 10.1902/jop.1997.68.11.1110.
PubMed 9407405
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Marginal Bone Level, Buccal and Palatal Plate Thickness Alteration, and Implant Stability After Placement in Healed Ridges and Fresh Extraction Sockets: A 6 Months Prospective Study.
- ClinicalTrials.gov ID
- NCT04346706
- Acronym / sponsor ID
- FMD124
- Conditions
- Tooth Extraction, Dental Implantation, Bone Remodeling
- Keywords
- Dental implantation, Immediate dental implant loading, Marginal bone remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 15 Apr 2020 (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.
The purpose of this prospective clinical study was to compare in delayed and immediately placed implants, the marginal vertical bone loss at 4 sides of the implant (buccal, palatal, mesial and distal), as well as the buccal and palatal bone thickness reduction at 3 months after loading.
Detailed description
Twenty-four patients were consecutively selected and enrolled in this study based on the aforementioned exclusion and inclusion criteria. Clinical examination was done by a different clinician than the operator, and according to the treatment indication, patients were allocated to the delayed implant placement group (Control), or the immediate implant placement group (Test). Thus, 15 implants were placed in healed extraction sites and immediately temporized (Control group), and 15 implants were placed in immediate extraction sites with immediate temporization (Test group).
Provisional acrylic crowns were prepared. All patients were placed on a prophylactic antibiotic regimen, starting one day prior to surgery as they were asked to take amoxicillin 500 mg; three times a day for 10 days or clindamycin 300 mg twice daily for 10 days for penicillin-allergic patients.
For the test group, tooth extractions were carried out atraumatically using periotomes. In both groups, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm.
Temporary abutments were connected to the implants and torqued at 20 Ncm, and then temporary crowns were cemented on top of the abutments after checking and reducing occlusion to non-existent in both centric and lateral excursions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implantation | Experimental | Device: Extraction and Implant insertion (test)Tooth extraction, immediate insertion of an implant with immediate temporization |
| Delayed implantation | Experimental | Device: Implant insertion (control)Implant inserted in a healed socket with immediate temporization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 18 years old, compliant (willing to show up to all their follow-up visits), and able to read, understand and sign an informed consent. All patients were to have good oral hygiene levels (full mouth plaque scores (FMPS) <15-20%, and full mouth bleeding index (FMBI) <15-20%), requiring implant insertion in a maxillary premolar site either immediately or in a healed "pristine bone".
Key exclusion criteria (1 listed)
- Presence of major contraindications to implant surgery, patients that had received head and neck radiation for cancer treatment, immunosuppressed or immunocompromised patients, uncontrolled diabetes, pregnant or breast-feeding woman, untreated periodontitis and/or poor oral hygiene and motivation, presence of buccal dehiscence, and finally previous bone grafting or ridge preservation in the studied area.
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 |
|---|---|---|
| Extraction and Implant insertion (test)The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated. Tooth extractions were carried out atraumatically using periotomes. Implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ, at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation. Absorbable interrupted 4.0 sutures were used for flap closure. | Device | Immediate implantation |
| Implant insertion (control)The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ. This was done at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation. Absorbable interrupted 4.0 sutures were used for flap closure. | Device | Delayed implantation |
Primary outcome
Change from baseline of marginal vertical bone level at 6 months
Time frame: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Marginal vertical bone level changes at 4 sides of the implant (buccal, palatal, mesial and distal) on Cone Beam Computed Tomography (CBCT) images
Change from baseline of bone plate thickness at 6 months
Time frame: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Buccal and palatal bone thickness at 4 levels : 0 mm, 2 mm, 4 mm and 6 mm from the implant platform on CBCT images
2 secondary outcomes
Change from baseline of implant stability quotient at 3 months
Time frame: Following procedure at day 0 (implant insertion) and 3 months (post-implantation)
Record of insertion torque
Time frame: Following procedure at day 0 (implant insertion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 22442783Penarrocha-Diago M, Demarchi CL, Maestre-Ferrin L, Carrillo C, Penarrocha-Oltra D, Penarrocha-Diago MA. A retrospective comparison of 1,022 implants: immediate versus nonimmediate. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):421-7.
- Background: PubMed 28517552Kim JK, Yoon HJ. Clinical and radiographic outcomes of immediate and delayed placement of dental implants in molar and premolar regions. Clin Implant Dent Relat Res. 2017 Aug;19(4):703-709. doi: 10.1111/cid.12496. Epub 2017 May 18.
- Background: PubMed 22276690Atieh MA, Alsabeeha NH, Duncan WJ, de Silva RK, Cullinan MP, Schwass D, Payne AG. Immediate single implant restorations in mandibular molar extraction sockets: a controlled clinical trial. Clin Oral Implants Res. 2013 May;24(5):484-96. doi: 10.1111/j.1600-0501.2011.02415.x. Epub 2012 Jan 26.
- Background: PubMed 28478869Mello CC, Lemos CAA, Verri FR, Dos Santos DM, Goiato MC, Pellizzer EP. Immediate implant placement into fresh extraction sockets versus delayed implants into healed sockets: A systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2017 Sep;46(9):1162-1177. doi: 10.1016/j.ijom.2017.03.016. Epub 2017 May 3.
- Background: PubMed 16731387Lindeboom JA, Tjiook Y, Kroon FH. Immediate placement of implants in periapical infected sites: a prospective randomized study in 50 patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Jun;101(6):705-10. doi: 10.1016/j.tripleo.2005.08.022. Epub 2006 Mar 22.
- Background: PubMed 25579008Rowan M, Lee D, Pi-Anfruns J, Shiffler P, Aghaloo T, Moy PK. Mechanical versus biological stability of immediate and delayed implant placement using resonance frequency analysis. J Oral Maxillofac Surg. 2015 Feb;73(2):253-7. doi: 10.1016/j.joms.2014.09.024. Epub 2014 Oct 13.
- Background: PubMed 28327692Esposito M, Zucchelli G, Cannizzaro G, Checchi L, Barausse C, Trullenque-Eriksson A, Felice P. Immediate, immediate-delayed (6 weeks) and delayed (4 months) post-extractive single implants: 1-year post-loading data from a randomised controlled trial. Eur J Oral Implantol. 2017;10(1):11-26.
- Background: PubMed 24550840Berberi AN, Sabbagh JM, Aboushelib MN, Noujeim ZF, Salameh ZA. A 5-year comparison of marginal bone level following immediate loading of single-tooth implants placed in healed alveolar ridges and extraction sockets in the maxilla. Front Physiol. 2014 Jan 31;5:29. doi: 10.3389/fphys.2014.00029. eCollection 2014.
- Background: PubMed 22897683Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x.
- Background: PubMed 22642261Ostman PO, Hellman M, Sennerby L. Ten years later. Results from a prospective single-centre clinical study on 121 oxidized (TiUnite) Branemark implants in 46 patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):852-60. doi: 10.1111/j.1708-8208.2012.00453.x. Epub 2012 May 29.
- Background: PubMed 15101597Romeo E, Lops D, Margutti E, Ghisolfi M, Chiapasco M, Vogel G. Long-term survival and success of oral implants in the treatment of full and partial arches: a 7-year prospective study with the ITI dental implant system. Int J Oral Maxillofac Implants. 2004 Mar-Apr;19(2):247-59.
- Background: PubMed 22220768Covani U, Chiappe G, Bosco M, Orlando B, Quaranta A, Barone A. A 10-year evaluation of implants placed in fresh extraction sockets: a prospective cohort study. J Periodontol. 2012 Oct;83(10):1226-34. doi: 10.1902/jop.2012.110583. Epub 2012 Jan 5.
- Individual participant dataSharing planned: Yes. Patient characteristics. Outcome measures
Related trials for Tooth Extraction
RecruitingObservational study
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Stomatognatic, Tooth Diseases
Not yet recruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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.
Nada Naaman, PhD study director
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction and Implant insertion (test) in people with Tooth Extraction and Dental Implantation, run by Saint-Joseph University at 1 site in Lebanon.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Apr 2020. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of marginal vertical bone level at 6 months (time frame: Following procedure at day 0 (implant insertion) and 6 months (post-implantation)). The study lists 2 primary outcomes in all. 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 NCT04346706, which also lists 38 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 15 Apr 2020.