Clinical trial NCT05526677: Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading
Official title: Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Single Missing Tooth Rehabilitation
Keywords: Single missing tooth
one-visit single-implant immediate loading
digital workflow
dynamic navigation
static surgical guide
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2022-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient older than 18 years old, including both sexes. Every patient has 2 missing teeth in a jaw and one on each side. All the edentulous ridges suit the immediate loading criteria

Brief summary: Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.


Eligibility criteria: Inclusion Criteria:

* 20 to 80 years old
* Miss two functional opposing teeth in one quadrant or the same jaw
* The situation of oral tissue satisfies the condition of implant immediate loading.

Exclusion Criteria:

* catastrophic illness,
* diabetes,
* cardiovascular diseases,
* osteoporosis,
* head and neck cancer,
* disabled
* pregnant.

Primary outcomes:
measure: Record visiting time
timeFrame: during procedure
measure: Implant success rate
timeFrame: Change in periapical film of the implant on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
measure: Prosthesis success rate
timeFrame: Change in photo on post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
measure: surgical complications
timeFrame: Post operation 1 week
measure: prosthetic success rates
timeFrame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
measure: Implant stability quotient (ISQ)
timeFrame: Change in post operation immediately, post operation 1 month, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Type of incision
timeFrame: during the operation
Other outcomes:
Locations:
Study officials:
References:
citation: Pozzi A, Arcuri L, Carosi P, Nardi A, Kan J. Clinical and radiological outcomes of novel digital workflow and dynamic navigation for single-implant immediate loading in aesthetic zone: 1-year prospective case series. Clin Oral Implants Res. 2021 Dec;32(12):1397-1410. doi: 10.1111/clr.13839. Epub 2021 Sep 8.
citation: Lopes A, de Araujo Nobre M, Santos D. The Workflow of a New Dynamic Navigation System for the Insertion of Dental Implants in the Rehabilitation of Edentulous Jaws: Report of Two Cases. J Clin Med. 2020 Feb 4;9(2):421. doi: 10.3390/jcm9020421.
citation: Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
citation: Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
citation: Dure M, Berlinghoff F, Kollmuss M, Hickel R, Huth KC. First comparison of a new dynamic navigation system and surgical guides for implantology: an in vitro study. Int J Comput Dent. 2021 Feb 26;24(1):9-17.
citation: Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.