An observational study in Implant Placement in Maxillary Esthetic Zone, sponsored by Fuming He. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Fuming He · Observational
This is the only study on the registry with Fuming He as lead sponsor.
Counted across the registry records on this site, refreshed daily.
From the date of ethics approval to June 2027, all patients who meet the inclusion criteria and who undergo implant placement in the maxillary anterior region with simultaneous guided bone regeneration (GBR) at the Stomatology Hospital, Zhejiang University School of Medicine.
Exclusion Criteria:
Bone resorption rate after guided bone regeneration
The cone beam computed tomography (CBCT) data from the three time points (on the day of the initial consultation (T0), immediately after surgery (T1) and six months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T1 and T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. V1 (volumes of the immediate bone increment) and V2 (volumes of the 6-month bone increment) can be accessed from the properties menu. The resorption rate of bone increment, denoted as RV, can be calculated by utilizing the formula (V1 -V2)/V1.
Time frame: From enrollment to the end of treatment at 6 months
Marginal Bone Loss
The Digital Imaging and Communications in Medicine (DICOM) datasets were imported into 3D Slicer software (Version 5.6.1) for processing and analysis. To ensure accurate longitudinal comparisons, all subsequent timepoint datasets (T1-T2) were superimposed onto the preoperative CBCT (T0), which served as the alignment reference. Spatial registration was performed using stable anatomical landmarks,. Registration accuracy was verified through iterative surface mapping and cross-sectional analysis of unchanged anatomical structures. Marginal bone level (MBL) was measured as the distance between the implant shoulder and the most coronal aspect of the alveolar crest on the facial side of the implant using a software program (NNT Viewer; NewTom). Marginal bone loss was defined as the difference in MBL between baseline and follow-up.
Time frame: From enrollment to the end of treatment at 6 months
probing depth (PD)
A periodontal probe (PCP-UNC 15, Hu-Friedy, Chicago, USA) was used with a standardized force of 0.2N to measure probing depth at four specific sites around each implant: buccal mesial, buccal mid, buccal distal, and lingual mid. The probe was posi- tioned parallel to the long axis of the implant at each site, and the probing depth was recorded individually. The mean value of these four measurements was calculated to represent the prob- ing depth (PD) for the implant during the assessment.
Time frame: From enrollment to the end of treatment at 6 months
bleeding on probing (BOP)
Bleeding on probing (BOP) was recorded as present or absent at each site immediately after probing. BOP% was calculated as the percentage of sites exhibiting bleeding among the six examined sites per implant.
Time frame: From enrollment to the end of treatment at 6 months
Plaque Index (PI)
Four surfaces (mesial, buccal, distal, lingual) were assessed per implant. The PI was scored from 0 to 3 based on the presence and visibility of plaque, without the use of disclosing agents. PI was calculated by summing the individual scores for each examined site and dividing by the total number of examined surfaces.
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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