Immediate Vs. Early Loading of Immediately Placed Implants

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2023-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immediate Loading in Single Tooth Implants

NCT05409287

Partial Edentulism Class 3

ACTIVE_NOT_RECRUITING NA

Immediate vs Conventional Loading for Early Implant Placement

NCT06526351

Dental Implant

RECRUITING NA

A Study of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects

NCT06068231

Dental Implant

UNKNOWN NA

Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment

NCT05668494

Bone Loss in Jaw

UNKNOWN NA

RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.

NCT05079542

Tooth Loss Dental Implant, Single-tooth

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objectives of the study

The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients. The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one, two and five years postoperatively. The gained results will assess and compared within partial and total edentulous patients.

Additionally, the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including (biological, mechanical, and procedure-related complications) comparing the their incidence between partial and total edentulous patients.

Materials and methods

The study is design as a prospective, randomised, controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki (World Medical Association, 2013) and the CONSORT Statement.

Before the treatment procedure, after clinical examination patients will be divided into two groups:

1. Group A- patient requires on both sides one implant to be placed
2. Group B- patient requires full-arch reconstruction

Thereafter, in the both groups, patients will be randomly divided into two subgroups in which immediate loading (test group) or early loading (six week postoperatively) will be performed.

Surgical procedure

One hour before the surgery, antibiotic prophylaxis will be administered, and the patients should rins their mouths with 0.12% chlorhexidine solution for 1 minute preoperatively. The procedures will be performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. A midcrestal incision will be made, and full-thickness will be elevated. Failing tooth or teeth will be extracted using periotomes, elevators, and forceps to preserve socket walls integrity. Extracted alveolus will be immediately prepared following by the epicrestal or subcrestal implant placement. If the gap between the implant surfaces and socket walls is wider than 2 mm, bovine-derived xenograft (Geistlich Bio-Oss®, Wolhusen, Switzerland) and collagen membrane (Geistlich Bio-Gide®, Wolhusen, Switzerland) will be placed. Healing screws (Institute Straumann AG, Basel, Switzerland; NC healing abutment ∅4.8 mm conical 5 mm and RC healing abutment ∅5 mm conical 6 mm) will be placed, and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Pully-Lausanne, Switzerland). The presence of apical fenestration, cortical dehiscence, an apico-marginal defect, or the need for contour augmentation will also recorded in the patient study charts. Patients will be prescribed antibiotic therapy for the next five days (Amoxicillin with clavulonic acid, 1 g, twice a day, or, in case of allergy, Clindamycin, 0.6 g, three times a day).

2.3 Prosthetic protocol

Implants in subgroup marked as the test group will be immediately loaded with temporary restorations using S-R abutments (Institute Straumann AG, Basel, Switzerland) whereas the patients from the subgroup marked as control group wouldn't receive any kind of prosthetic restauration, and will left with healing abutments (HA).

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 in both groups.

Data Collection and measurements

Implant stability, assessed as the primary study outcome, was measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) (Fig. 7b) and Penguin® (PenguinRFA, Gothenburg, Sweden).

Marginal bone loss will be assessed as the difference between the postoperative and followed up years by means of CBCT measurements.

The distance between the implant shoulder and the crestal bone will be estimated as the shortest distance, using the same HA for each patient.

The results will be statistically analysed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Implant Complication Implant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test: Immediate implant loading

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

Group Type EXPERIMENTAL

Immediate implant loading

Intervention Type 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.

Control: Early implant loading

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

Group Type EXPERIMENTAL

Early implant loading

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immediate implant loading

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.

Intervention Type DEVICE

Early implant loading

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

test group control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes