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Partial Edentulism of the MaxillaNCT07381283

Immediate Versus Delayed Loading of Dental Implants in the Anterior Maxilla

A study testing Dental Implant in people with Partial Edentulism of the Maxilla and Dental Implant Loading, run by Suez Canal University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
What is being tested?
Dental Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
3 Feb 2024to 12 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Suez Canal University, Faculty of Dentistry

    Ismailia

Other trials in Egypt

About this study

Official title: 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.

Being tested
Dental Implant
Keywords
Dental Implants, Immediate Loading, Delayed Loading, Maxillary Implants, Anterior Maxilla, Partial Edentulism, Implant Stability, Osseointegration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental ImplantDevice

    Endosseous dental implants placed in the anterior maxilla and restored using either immediate or delayed loading protocols.

Study groups in NCT07381283
Study groupRoleWhat they receive
Delayed Loading GroupActive comparatorParticipants 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.
Receives: Device: Dental Implant
Immediate Loading GroupExperimentalParticipants 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.
Receives: Device: Dental Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Stability (ISQ)

    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.

    Measured: Baseline (immediately after implant placement) and 6 months postoperatively

  2. Peri-implant Bone Density

    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.

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (2)

  1. Postoperative Pain (Visual Analog Scale, VAS)

    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.

    Measured: 1, 3, and 7 days postoperatively

  2. Visual Scale of Edema

    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.

    Measured: 1, 3, and 7 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start3 Feb 2024
  3. Primary completion21 May 2025
  4. Study completion12 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381283
Sponsor's protocol ID
706/2023
Status last verified
Dec 2025
First submitted
25 Jan 2026
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim HS, Cho HA, Kim YY, Shin H. Implant survival and patient satisfaction in completely edentulous patients with immediate placement of implants: a retrospective study. BMC Oral Health. 2018 Dec 18;18(1):219. doi: 10.1186/s12903-018-0669-1.

    PubMed 30563482

  • Gallucci GO, Hamilton A, Zhou W, Buser D, Chen S. Implant placement and loading protocols in partially edentulous patients: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:106-134. doi: 10.1111/clr.13276.

    PubMed 30328194

  • Fischer K, Stenberg T, Hedin M, Sennerby L. Five-year results from a randomized, controlled trial on early and delayed loading of implants supporting full-arch prosthesis in the edentulous maxilla. Clin Oral Implants Res. 2008 May;19(5):433-41. doi: 10.1111/j.1600-0501.2007.01510.x. Epub 2008 Mar 26.

    PubMed 18371094

  • Eliasziw M, Young SL, Woodbury MG, Fryday-Field K. Statistical methodology for the concurrent assessment of interrater and intrarater reliability: using goniometric measurements as an example. Phys Ther. 1994 Aug;74(8):777-88. doi: 10.1093/ptj/74.8.777.

    PubMed 8047565

  • Cohen, J. 1988. Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey: Lawrence Erlbaum Associates.

  • Bergkvist G, Sahlholm S, Nilner K, Lindh C. Implant-supported fixed prostheses in the edentulous maxilla. A 2-year clinical and radiological follow-up of treatment with non-submerged ITI implants. Clin Oral Implants Res. 2004 Jun;15(3):351-9. doi: 10.1111/j.1600-0501.2004.01017.x.

    PubMed 15142099

  • Bergkvist G, Nilner K, Sahlholm S, Karlsson U, Lindh C. Immediate loading of implants in the edentulous maxilla: use of an interim fixed prosthesis followed by a permanent fixed prosthesis: a 32-month prospective radiological and clinical study. Clin Implant Dent Relat Res. 2009 Mar;11(1):1-10. doi: 10.1111/j.1708-8208.2008.00094.x. Epub 2008 Apr 1.

    PubMed 18384401

  • Hassanin Atia MG, Hamed MS, Abdallah AY, Younis AA. Clinical and radiographic evaluation of immediate versus delayed loading of dental implants at anterior maxilla: a randomized controlled trial. BMC Oral Health. 2026 Oct 2;26(1):1921. doi: 10.1186/s12903-026-09843-w.

    PubMed 42834394

Questions about this trial

What is this clinical trial studying?

A study testing Dental Implant in people with Partial Edentulism of the Maxilla and Dental Implant Loading, run by Suez Canal University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Stability (ISQ) (time frame: Baseline (immediately after implant placement) and 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381283, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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