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NCT Number: NCT07381283

Immediate Versus Delayed Loading of Dental Implants in 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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implant

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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