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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant | Device | Endosseous dental implants placed in the anterior maxilla and restored using either immediate or delayed loading protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3, and 7 days postoperatively |
| Visual Scale of Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University, Faculty of Dentistry | Ismailia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30563482 | Background | 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. | |
| 30328194 | 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. |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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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 |
| 18371094 | 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. |
| 8047565 | 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. |
| Background | Cohen, J. 1988. Statistical power analysis for the behavioral sciences. Hillsdale, New Jersey: Lawrence Erlbaum Associates. |
| 15142099 | 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. |
| 18384401 | 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. |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |