Immediate Versus Delayed Loading of Dental Implants in the Anterior Maxilla

NCT07381283 | Completed

• 1 other identifier: 706/2023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Partial Edentulism of the Maxilla; Dental Implant Loading; Tooth Loss in the Anterior Maxilla

Keywords

Dental Implants; Immediate Loading; Delayed Loading; Maxillary Implants; Anterior Maxilla; Partial Edentulism; Implant Stability; Osseointegration

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (immediately after implant placement) and 6 months postoperatively

• 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.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

• Postoperative Pain (Visual Analog Scale, VAS)

  1, 3, and 7 days postoperatively

• Visual Scale of Edema

  1, 3, and 7 days postoperatively

Study Arms (2)

Delayed Loading Group

ACTIVE COMPARATOR

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

Immediate Loading Group

EXPERIMENTAL

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

Interventions

Dental Implant DEVICE

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

Delayed Loading Group; Immediate Loading Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, Egypt

Location

Related Publications (7)

• 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.

  PMID: 30563482 BACKGROUND

• 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.

  PMID: 30328194 BACKGROUND

• 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.

  PMID: 18371094 BACKGROUND

• 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.

  PMID: 8047565 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15142099 BACKGROUND

• 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.

  PMID: 18384401 BACKGROUND

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mohamed Said Hamed, Professor

  Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry - Suez Canal University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: February 3, 2024
• Primary Completion: May 21, 2025
• Study Completion: October 12, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)