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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04346706
Other study ID # FMD124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2018
Est. completion date November 25, 2019

Study information

Verified date April 2020
Source Saint-Joseph University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 25, 2019
Est. primary completion date July 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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".

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Lebanon Saint-Joseph University Beirut

Sponsors (1)

Lead Sponsor Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (37)

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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. — View Citation

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Buser D, Janner SF, Wittneben JG, Brägger 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. — View Citation

Buser D, Wittneben J, Bornstein MM, Grütter 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. — View Citation

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. Epub 2012 Jan 5. — View Citation

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. — View Citation

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. — View Citation

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Galindo-Moreno P, León-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Apr 18. — View Citation

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. Epub 2006 Mar 22. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

Östman PO, Hellman M, Sennerby L. Ten years later. Results from a prospective single-centre clinical study on 121 oxidized (TiUnite™) Brånemark 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. — View Citation

Peñarrocha-Diago M, Demarchi CL, Maestre-Ferrín L, Carrillo C, Peñarrocha-Oltra D, Peñarrocha-Diago MA. A retrospective comparison of 1,022 implants: immediate versus nonimmediate. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):421-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vignoletti F, Sanz-Esporrin J, Sanz-Martin I, Nuñez 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. — View Citation

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. Review. — View Citation

* Note: There are 37 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Primary 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 Following procedure at day 0 (implant insertion) and 6 months (post-implantation)
Secondary Change from baseline of implant stability quotient at 3 months Measurements of implant stability quotient (ISQ) following implant insertion Following procedure at day 0 (implant insertion) and 3 months (post-implantation)
Secondary Record of insertion torque Insertion torque value at implant placement Following procedure at day 0 (implant insertion)
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