Immediate Implant Placement in Fresh Extraction Sockets and Delayed Implants in Healed Sockets.
NCT ID: NCT04346706
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2018-02-10
2019-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.
NCT05880771
Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone
NCT04343066
Association Between Restorative Emergence Profiles and Peri-implant Bone Loss in Different Implant Systems:
NCT06544746
Immediate Implant Placement Using the Socket Shield Technique in Maxillary Esthetic Zone
NCT07082634
Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
NCT04327284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate implantation
Tooth extraction, immediate insertion of an implant with immediate temporization
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.
Delayed implantation
Implant inserted in a healed socket with immediate temporization
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saint-Joseph University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nada BOU ABBOUD NAAMAN
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nada Naaman, PhD
Role: STUDY_DIRECTOR
Saint-Joseph University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Saint-Joseph University
Beirut, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kim 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.
Atieh 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.
Mello 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.
Lindeboom 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.
Rowan 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.
Esposito 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.
Berberi 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.
Buser 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.
Ostman 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.
Romeo 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.
Covani 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.
Fugazzotto 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.
Gher 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.
Schwartz-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.
Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
Meredith N, Shagaldi F, Alleyne D, Sennerby L, Cawley P. The application of resonance frequency measurements to study the stability of titanium implants during healing in the rabbit tibia. Clin Oral Implants Res. 1997 Jun;8(3):234-43. doi: 10.1034/j.1600-0501.1997.080310.x.
Orlando B, Barone A, Giorno TM, Giacomelli L, Tonelli P, Covani U. Insertion torque in different bone models with different screw pitch: an in vitro study. Int J Oral Maxillofac Implants. 2010 Sep-Oct;25(5):883-7.
Zimmermann J, Sommer M, Grize L, Stubinger S. Marginal bone loss 1 year after implantation: a systematic review for fixed and removable restorations. Clin Cosmet Investig Dent. 2019 Jul 16;11:195-218. doi: 10.2147/CCIDE.S208076. eCollection 2019.
Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, O Valle F, Catena A. Marginal bone loss as success criterion in implant dentistry: beyond 2 mm. Clin Oral Implants Res. 2015 Apr;26(4):e28-e34. doi: 10.1111/clr.12324. Epub 2014 Jan 3.
Vignoletti F, Sanz-Esporrin J, Sanz-Martin I, Nunez J, Luengo F, Sanz M. Ridge alterations after implant placement in fresh extraction sockets or in healed crests: An experimental in vivo investigation. Clin Oral Implants Res. 2019 Apr;30(4):353-363. doi: 10.1111/clr.13421. Epub 2019 Apr 3.
Juodzbalys G, Wang HL. Esthetic index for anterior maxillary implant-supported restorations. J Periodontol. 2010 Jan;81(1):34-42. doi: 10.1902/jop.2009.090385.
Buser D, Wittneben J, Bornstein MM, Grutter L, Chappuis V, Belser UC. Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year results of a prospective study with early implant placement postextraction. J Periodontol. 2011 Mar;82(3):342-9. doi: 10.1902/jop.2010.100408. Epub 2010 Sep 10.
Esposito M, Klinge B, Meyle J, Mombelli A, Rompen E, van Steenberghe D, Van Dyke T, Wang HL, van Winkelhoff AJ. Working Group on the Treatment Options for the Maintenance of Marginal Bone Around Endosseous Oral Implants, Stockholm, Sweden, 8 and 9 September 2011. Consensus statements. Eur J Oral Implantol. 2012;5 Suppl:S105-6. No abstract available.
Ormianer Z, Piek D, Livne S, Lavi D, Zafrir G, Palti A, Harel N. Retrospective clinical evaluation of tapered implants: 10-year follow-up of delayed and immediate placement of maxillary implants. Implant Dent. 2012 Aug;21(4):350-6. doi: 10.1097/ID.0b013e31825feb16.
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Araujo 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.
Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
Tarnow DP, Cho SC, Wallace SS. The effect of inter-implant distance on the height of inter-implant bone crest. J Periodontol. 2000 Apr;71(4):546-9. doi: 10.1902/jop.2000.71.4.546.
Hermann JS, Cochran DL, Nummikoski PV, Buser D. Crestal bone changes around titanium implants. A radiographic evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. J Periodontol. 1997 Nov;68(11):1117-30. doi: 10.1902/jop.1997.68.11.1117.
Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
Puisys A, Auzbikaviciute V, Minkauskaite A, Simkunaite-Rizgeliene R, Razukevicius D, Linkevicius R, Linkevicius T. Early crestal bone loss: Is it really loss? Clin Case Rep. 2019 Aug 27;7(10):1913-1915. doi: 10.1002/ccr3.2376. eCollection 2019 Oct.
O'Sullivan D, Sennerby L, Jagger D, Meredith N. A comparison of two methods of enhancing implant primary stability. Clin Implant Dent Relat Res. 2004;6(1):48-57. doi: 10.1111/j.1708-8208.2004.tb00027.x.
Nedir R, Bischof M, Szmukler-Moncler S, Bernard JP, Samson J. Predicting osseointegration by means of implant primary stability. Clin Oral Implants Res. 2004 Oct;15(5):520-8. doi: 10.1111/j.1600-0501.2004.01059.x.
Lages FS, Douglas-de Oliveira DW, Costa FO. Relationship between implant stability measurements obtained by insertion torque and resonance frequency analysis: A systematic review. Clin Implant Dent Relat Res. 2018 Feb;20(1):26-33. doi: 10.1111/cid.12565. Epub 2017 Dec 1.
Berglundh T, Lindhe J. Healing around implants placed in bone defects treated with Bio-Oss. An experimental study in the dog. Clin Oral Implants Res. 1997 Apr;8(2):117-24. doi: 10.1034/j.1600-0501.1997.080206.x.
Lee DW, Choi YS, Park KH, Kim CS, Moon IS. Effect of microthread on the maintenance of marginal bone level: a 3-year prospective study. Clin Oral Implants Res. 2007 Aug;18(4):465-70. doi: 10.1111/j.1600-0501.2007.01302.x. Epub 2007 Apr 18.
Dagher M, Mokbel N, Aboukhalil R, Ghosn N, Kassir A, Naaman N. Marginal Bone Level and Bone Thickness Reduction in Delayed and Immediate Implant Placement Protocol 6 Months Post-loading: An Observational Clinical Prospective Study. J Maxillofac Oral Surg. 2022 Jun;21(2):571-579. doi: 10.1007/s12663-021-01673-3. Epub 2022 Jan 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FMD124
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.