- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381283
Immediate Versus Delayed Loading of Dental Implants in the Anterior Maxilla
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ismailia, Egypt
- Suez Canal University, Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
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Endosseous dental implants placed in the anterior maxilla and restored using either immediate or delayed loading protocols.
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|
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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability (ISQ)
Time Frame: Baseline (immediately after implant placement) and 6 months postoperatively
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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.
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Baseline (immediately after implant placement) and 6 months postoperatively
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Peri-implant Bone Density
Time Frame: Baseline, 3 months, 6 months
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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.
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Baseline, 3 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain (Visual Analog Scale, VAS)
Time Frame: 1, 3, and 7 days postoperatively
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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.
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1, 3, and 7 days postoperatively
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Visual Scale of Edema
Time Frame: 1, 3, and 7 days postoperatively
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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.
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1, 3, and 7 days postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- 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
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 706/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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