Immediate Vs. Early Loading of Immediately Placed Implants

NCT05869292 | Completed

• 1 other identifier: 36/16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five years of follow-ups.

Conditions

Implant Complication; Implant

Keywords

immediate loading; Early loading; Marginal Bone Loss; Implant stability; Immediate implant placement

Outcome Measures

Primary Outcomes (3)

• Implant stability

  Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.

  Change implant stability at 12 months

• Implant stability

  Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.

  Change implant stability at 2 years

• Implant stability

  Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.

  Change implant stability at 5 years

Secondary Outcomes (6)

• Change of Marginal bone loss (MBL)

  Change baseline marginal bone at 12 months

• Change of Marginal bone loss (MBL)

  Change baseline marginal bone at 2 years

• Change of Marginal bone loss (MBL)

  Change baseline marginal bone at 5 years

• Change of keratinised tissue width (KTW)

  Change baseline marginal bone at 12 months

• Change of keratinised tissue width (KTW)

  Change baseline marginal bone at 2 years

Other Outcomes (6)

• Patient satisfaction

  12 moths postoperatively

• Patient satisfaction

  2 years postoperatively

• Patient satisfaction

  5 years postoperatively

Study Arms (2)

Test: Immediate implant loading

EXPERIMENTAL

Implants will be immediately following surgical procedure loaded with temporary restorations.

Device: Immediate implant loading

Control: Early implant loading

EXPERIMENTAL

Implants will not be received prosthetic restoration, and will left with healing abutments (HA) for 6 weeks.

Device: Early implant loading

Interventions

Immediate implant loading DEVICE

Implants will be received immediately prosthetic restoration following surgical procedure. For the provisional restoration, an open tray impression technique will be used. Plaster models with scan bodies will be digitized by the laboratory scanner (3Shape E1, 3Shape, Kopenhagen, Denmark), and the virtual design of provisional restoration will be performed with 3D designing software (Exocad-Matera 2.3, Exocad, Darmstadt, Germany). Provisional restorations will be then created using polymethyl methacrylate (PMMA) (Telio®CAD, Ivoclar Vivadent, Schaan, Lichtenstein) and were drilled from PMMA blocks using the 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). Screw-retained abutments for the prosthetic bridge will be chosen according to implant angulation and surrounding soft tissue height. At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients.

Also known as: test group

Test: Immediate implant loading

Early implant loading DEVICE

Implants won't receive immediately prosthetic restoration following surgical procedure and will be left only healing caps. At the end of the six-week healing period, definitive prosthetic restorations will be manufactured and delivered to the patients.

Also known as: control group

Control: Early implant loading

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age;
• systemically healthy;
• periodontally healthy or with stable treated periodontitis and good oral hygiene (FMPS and FMBS ≤ 15%, measured at six sites per tooth)
• Have maxillary dentition with one or multiple failing teeth
• Have sufficient bone volume to immediately place implants
• Non-smoker or light smoker

You may not qualify if:

• An active or chronic disease that affects bone metabolism or wound healing (ASA III type);
• Diminished mental capacities that could mitigate the ability to comply with the protocol;
• History of maxillary augmentation; oral carcinoma or inflammatory changes;
• History of head and neck radiotherapy.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental Medicine, Univeristy of Blegrade

Belgrade, 11000, Serbia

Location

Related Publications (6)

• Chambrone L, Shibli JA, Mercurio CE, Cardoso B, Preshaw PM. Efficacy of standard (SLA) and modified sandblasted and acid-etched (SLActive) dental implants in promoting immediate and/or early occlusal loading protocols: a systematic review of prospective studies. Clin Oral Implants Res. 2015 Apr;26(4):359-370. doi: 10.1111/clr.12347. Epub 2014 Feb 21.

  PMID: 24814519 BACKGROUND

• Chung S, McCullagh A, Irinakis T. Immediate loading in the maxillary arch: evidence-based guidelines to improve success rates: a review. J Oral Implantol. 2011 Oct;37(5):610-21. doi: 10.1563/AAID-D-JOI-10-00058.1.

  PMID: 22004059 BACKGROUND

• Del Fabbro M, Testori T, Kekovic V, Goker F, Tumedei M, Wang HL. A Systematic Review of Survival Rates of Osseointegrated Implants in Fully and Partially Edentulous Patients Following Immediate Loading. J Clin Med. 2019 Dec 4;8(12):2142. doi: 10.3390/jcm8122142.

  PMID: 31817177 BACKGROUND

• Garcia-Sanchez R, Dopico J, Kalemaj Z, Buti J, Pardo Zamora G, Mardas N. Comparison of clinical outcomes of immediate versus delayed placement of dental implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Mar;33(3):231-277. doi: 10.1111/clr.13892. Epub 2022 Jan 28.

  PMID: 35044012 BACKGROUND

• Ibrahim A, Chrcanovic BR. Dental Implants Inserted in Fresh Extraction Sockets versus Healed Sites: A Systematic Review and Meta-Analysis. Materials (Basel). 2021 Dec 20;14(24):7903. doi: 10.3390/ma14247903.

  PMID: 34947493 BACKGROUND

• Markovic A, Misic T, Janjic B, Scepanovic M, Trifkovic B, Ilic B, Todorovic AM, Markovic J, Dard MM. Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. J Oral Implantol. 2022 Oct 1;48(5):358-369. doi: 10.1563/aaid-joi-D-21-00045.

  PMID: 34937085 BACKGROUND

MeSH Terms

Interventions

Immediate Dental Implant Loading; Control Groups

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aleksa Markovic, Professor

  School of Dental Medicine, University of Belgrade

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only investigators who will assess outcome including radiographic assessment, clinical outcomes and patients clinicians' satisfaction will be blinded all time. These investigators would not be familiar with group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is design as a prospective, randomised, controlled clinical trial. Depending on number of extracted teeth patients will be randomly allocated into Test group in which immediate loading following surgical procedure will be conducted Control group in which early loading (six weeks postoperatively) will be performed.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: January 31, 2019
• Primary Completion: May 15, 2021
• Study Completion: May 1, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2022-2035
• Access Criteria: The investigators will be shared analyzed outcomes and surgical procedure protocols

Locations

SE (1)