abutment placement
ProcedurePlacement of a subcrestal implant at more than 35 N and placement of a trans-epithelial abutment at 30 N
NCT Number: NCT06629961
Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. This technique increases the implant's horizontal surface area for biological width establishment and reduces stress on the crestal bone.
Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants, leading to an apical shift in the connective tissue junction and vertical tissue loss. This led to the "one abutment, one time" protocol, advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing.
A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection, despite different treatment protocols. Thus, a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels. This approach moves the biological width apically, protecting the bone from irritation and improving marginal bone isolation.
However, comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking. This study aims to evaluate the "one abutment, one time" protocol's effect on bone loss 12 months after prosthesis placement.
Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures (PROM) during prosthesis fabrication and placement, and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement.
Throughout the prosthesis fabrication and the first 12 months, various evaluations will be conducted in both abutment and Ti-base groups:
* **Bleeding:** Recorded during various prosthetic stages. * **Pain:** Assessed using a visual analog scale after each stage. * **Anesthesia:** Recorded if used at each stage. * **Radiographs:** Number taken to check the fit. * **Time:** Measured for each prosthetic phase. * **Repetitions:** Number of repeated procedures quantified. * **Metagenomic tests:** Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis, Valencia, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of a subcrestal implant at more than 35 N and placement of a trans-epithelial abutment at 30 N
Placement of a subcrestal implant at more than 35 N and placement of a Tibase placement at 30 N
Time frame: 12 months
The peri-implant marginal bone level was measured using Image J software from the National Institutes of Health with an accuracy of 0.1 mm. A straight line was drawn at the implant platform level (representing zero height), and perpendicular lines were drawn from the mesial and distal sides of the platform to measure the distance to the bone level on each side
University of Valencia
Other
Impact of Connection and Disconnection of the Transepithelial Abutment in Dental Implants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06166316
Behavior, Bone Diseases
Al Mansurah, Egypt
View Trial DetailsNCT04618900
Behavior, Bone Diseases
Aalborg, North Denmark, Denmark
View Trial DetailsNCT05286866
Bone Diseases, Bone Diseases, Metabolic
Valencia, Spain
View Trial DetailsNCT04742010
Atrophy, Bariatric Surgery
Esbjerg, Denmark
View Trial Details