Implant Complication Clinical Trial
Official title:
Immediate Vs. Early Loading of Immediately Placed Bone Level Tapered Dental Implants
NCT number | NCT05869292 |
Other study ID # | 36/16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 31, 2019 |
Est. completion date | May 1, 2023 |
Verified date | May 2023 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five years of follow-ups.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adults = 18 years of age; 2. systemically healthy; 3. periodontally healthy or with stable treated periodontitis and good oral hygiene (FMPS and FMBS = 15%, measured at six sites per tooth) 4. Have maxillary dentition with one or multiple failing teeth 5. Have sufficient bone volume to immediately place implants 6. Non-smoker or light smoker Exclusion Criteria: 1. An active or chronic disease that affects bone metabolism or wound healing (ASA III type); 2. Diminished mental capacities that could mitigate the ability to comply with the protocol; 3. History of maxillary augmentation; oral carcinoma or inflammatory changes; 4. History of head and neck radiotherapy. |
Country | Name | City | State |
---|---|---|---|
Serbia | School of Dental Medicine, Univeristy of Blegrade | Belgrad |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Chambrone L, Shibli JA, Mercurio CE, Cardoso B, Preshaw PM. Efficacy of standard (SLA) and modified sandblasted and acid-etched (SLActive) dental implants in promoting immediate and/or early occlusal loading protocols: a systematic review of prospective studies. Clin Oral Implants Res. 2015 Apr;26(4):359-370. doi: 10.1111/clr.12347. Epub 2014 Feb 21. — View Citation
Chung S, McCullagh A, Irinakis T. Immediate loading in the maxillary arch: evidence-based guidelines to improve success rates: a review. J Oral Implantol. 2011 Oct;37(5):610-21. doi: 10.1563/AAID-D-JOI-10-00058.1. — View Citation
Del Fabbro M, Testori T, Kekovic V, Goker F, Tumedei M, Wang HL. A Systematic Review of Survival Rates of Osseointegrated Implants in Fully and Partially Edentulous Patients Following Immediate Loading. J Clin Med. 2019 Dec 4;8(12):2142. doi: 10.3390/jcm8122142. — View Citation
Garcia-Sanchez R, Dopico J, Kalemaj Z, Buti J, Pardo Zamora G, Mardas N. Comparison of clinical outcomes of immediate versus delayed placement of dental implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Mar;33(3):231-277. doi: 10.1111/clr.13892. Epub 2022 Jan 28. — View Citation
Ibrahim A, Chrcanovic BR. Dental Implants Inserted in Fresh Extraction Sockets versus Healed Sites: A Systematic Review and Meta-Analysis. Materials (Basel). 2021 Dec 20;14(24):7903. doi: 10.3390/ma14247903. — View Citation
Markovic A, Misic T, Janjic B, Scepanovic M, Trifkovic B, Ilic B, Todorovic AM, Markovic J, Dard MM. Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. J Oral Implantol. 2022 Oct 1;48(5):358-369. doi: 10.1563/aaid-joi-D-21-00045. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient satisfaction | Patient will be recorded by using visual analog score (VAS). Patients will indicate their satisfaction relating to function, aesthetics, and discomfort/pain. | 12 moths postoperatively | |
Other | Patient satisfaction | Patient will be recorded by using visual analog score (VAS). Patients will indicate their satisfaction relating to function, aesthetics, and discomfort/pain. | 2 years postoperatively | |
Other | Patient satisfaction | Patient will be recorded by using visual analog score (VAS). Patients will indicate their satisfaction relating to function, aesthetics, and discomfort/pain. | 5 years postoperatively | |
Other | Pink aesthetic score (PES) | A clinical photograph performed at 12 months examination, will be used for assessment.
Seven variables of the implant supported crown will be evaluated vs. a contralateral natural tooth: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture. A 0-1-2 scoring system will be used, 0 being the lowest and 2 being the highest value. |
12 months after implant loading | |
Other | Pink aesthetic score (PES) | A clinical photograph performed at 2 years examination, will be used for assessment.
Seven variables of the implant supported crown will be evaluated vs. a contralateral natural tooth: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture. A 0-1-2 scoring system will be used, 0 being the lowest and 2 being the highest value. |
2 years after implant loading | |
Other | Pink aesthetic score (PES) | A clinical photograph performed at 5 years examination, will be used for assessment.
Seven variables of the implant supported crown will be evaluated vs. a contralateral natural tooth: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture. A 0-1-2 scoring system will be used, 0 being the lowest and 2 being the highest value. |
5 years after implant loading | |
Primary | Implant stability | Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values. | Change implant stability at 12 months | |
Primary | Implant stability | Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values. | Change implant stability at 2 years | |
Primary | Implant stability | Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values. | Change implant stability at 5 years | |
Secondary | Change of Marginal bone loss (MBL) | MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT. | Change baseline marginal bone at 12 months | |
Secondary | Change of Marginal bone loss (MBL) | MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT. | Change baseline marginal bone at 2 years | |
Secondary | Change of Marginal bone loss (MBL) | MBL will be measured in millimetres as distance between the implant shoulder and the crestal bone postoperative and one, second, and five year postoperatively by using CBCT. | Change baseline marginal bone at 5 years | |
Secondary | Change of keratinised tissue width (KTW) | KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ) | Change baseline marginal bone at 12 months | |
Secondary | Change of keratinised tissue width (KTW) | KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ) | Change baseline marginal bone at 2 years | |
Secondary | Change of keratinised tissue width (KTW) | KTW will be measured in millimetres at the middle of the inserted implant as the distance between the free MM to a mucogingival junction (MGJ) | Change baseline marginal bone at 5 years |
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