Immediate Versus Delayed Loading of Dental Implants in the Anterior Maxilla

January 25, 2026 updated by: Suez Canal University

Clinical and Radiographic Evaluation of Immediate Versus Delayed Loading of Dental Implants at the Anterior Maxilla

This interventional comparative clinical study was conducted to evaluate and compare the clinical stability and radiographic outcomes of immediate versus delayed loading of dental implants placed in the anterior region of the maxilla. Immediate loading protocols have been shown to improve oral health-related quality of life and patient satisfaction; however, their influence on implant stability and osseointegration remains an area of ongoing investigation.

A total of sixteen dental implants were placed and the participants were randomly allocated into two equal groups using a computer-generated randomization method (www.Randomizer.org). In Group I (control group), eight implants were placed and restored following a delayed loading protocol, with prosthetic loading performed six months after implant placement. In Group II (study group), eight implants were placed and immediately loaded with provisional polymethyl methacrylate (PMMA) restorations. After six months, the provisional restorations were replaced with definitive fixed prostheses.

Preoperative planning of implant placement was performed using cone beam computed tomography (CBCT). Clinical evaluation of implant stability was carried out using the Osstell device, while radiographic assessment of peri-implant bone density and marginal bone changes was performed using standardized indirect digital radiographs. Radiographic evaluations were obtained immediately after implant placement and at six months postoperatively. The clinical and radiographic outcomes of both loading protocols were compared to assess implant stability and osseointegration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Suez Canal University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 20-55 years
  • Both genders
  • Healthy individuals (ASA I) without systemic diseases
  • Patients with one or more missing teeth in the anterior maxilla

Exclusion Criteria:

  • Pregnant or lactating women, or females with osteoporosis
  • Patients with harmful oral habits such as bruxism or smoking
  • Poor oral hygiene
  • Gingival or periodontal diseases with severe vertical or horizontal bone loss
  • Teeth with periapical or lateral infections or lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Delayed Loading Group
Participants in this group received a single dental implant placed in the anterior maxilla. A total of eight implants were placed and restored using a delayed loading protocol, with prosthetic loading performed six months after implant placement.
Device: Dental Implant
Endosseous dental implants placed in the anterior maxilla and restored using either immediate or delayed loading protocols.
Experimental: Immediate Loading Group
Participants in this group received a single dental implant placed in the anterior maxilla. A total of eight implants were placed and immediately loaded with provisional restorations. After six months, the provisional restorations were replaced with definitive fixed restorations.
Device: Dental Implant
Endosseous dental implants placed in the anterior maxilla and restored using either immediate or delayed loading protocols.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant Stability (ISQ)
Time Frame: Baseline (immediately after implant placement) and 6 months postoperatively
Clinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and <60 low stability.
Baseline (immediately after implant placement) and 6 months postoperatively
Peri-implant Bone Density
Time Frame: Baseline, 3 months, 6 months
Bone density around the implants was measured using standardized direct paralleling digital periapical radiographs and analyzed with IDRISI Kilimanjaro software. Two zones were evaluated: the osseointegration zone near the implant border and the surrounding bone interface. Measurements were recorded immediately postoperatively and at 3 and 6 months.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain (Visual Analog Scale, VAS)
Time Frame: 1, 3, and 7 days postoperatively
Patients reported the degree of pain using a 10-cm visual analog scale (VAS), where 0 = no pain and 10 = worst possible pain. Pain was assessed at 1, 3, and 7 days postoperatively.
1, 3, and 7 days postoperatively
Visual Scale of Edema
Time Frame: 1, 3, and 7 days postoperatively
Facial edema was assessed using a visual grading scale: No edema, Low-grade, Intermediate-grade, and High-grade, based on visual inspection and palpation. Edema was evaluated at 1, 3, and 7 days postoperatively.
1, 3, and 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suez Canal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mohamed Said Hamed, Professor, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University
  • Study Director: Asmaa Yousri Abdallah, Assistant professor, Assistant professor of Oral Radiology, Faculty of Dentistry
  • Study Director: Ahmed Abd elmohsen Younis, Assistant professor, Assistant Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 706/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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