Cairo University
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT07509476
The goal of this clinical trial is to assess the effect of distance between the implant and the bone on the resultant bone thickness adjacent to the implant in place of a broken down tooth that happens to be bounded by two natural teeth.
The main questions it aims to answer are:
Does the horizontal implant position (and hence the gap between the implant and the socket wall i.e. jumping gap) affect the resultant labial bone thickness? Will it affect the quality of soft tissue, esthetics and patient satisfaction?
Participants will have an implant placed using a surgical guide with a jumping gap either less than 2 mm or equal or more than 2 mm and will be asked to visit the clinic once every 3 months for checkups, radiographs, and readings.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Tooth replacement with dental implants in the esthetic zone is often accompanied with esthetic complications such as mid-facial gingival recession, implant thread exposure and a concave contour. Various methods have been introduced to minimize the occurrence of such complications, including applying connective tissue grafts, grafting the jumping gap, performing immediate temporization and using surgical guides to ensure the placement of the implant in the optimal prosthetic position.(El Ebiary et al., 2023)
It would be beneficial to establish an evidence-based protocol for the jumping gap distance to follow through, with all immediate implants in the aesthetic zone, most of which have thin labial bone to begin with. Though there have been multiple studies conducted, specifically in the past few years, there is insufficient evidence that tells us what the optimal jumping gap is. (Hamilton et al., 2023) (Lambert et al., 2023).
Therefore, the aim of our study is to evaluate this survival rate and the amount of change in labial bone thickness that will result in different horizontal defect dimensions (HDD) ≤ 2 mm in comparison to the > 2 mm HDD.
The study will be conducted at the department of periodontology at the faculty of dentistry, Cairo University, Egypt. Patients will be selected from the outpatient clinic at the faculty of dentistry, Cairo University, Egypt. Patients screening will be carried out until the target sample is achieved.
Pre-operative phase:
Clinical evaluation:
Radiographic examination:
A preoperative CBCT will be performed for patients who met the inclusion criteria to ensure their eligibility prior to surgery. (Joshi and Gupta, 2015)
Patient Preparation:
Surgical phase:
Post-operative instructions:
Follow-up:
Each patient will be evaluated at 3, 6, 9 and 12 months post-operatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
9- Alcohol abuse (Block et al., 2009) cited in (Soegiantho et al., 2023)
surgically guided placement of a single immediate post-extraction implant in the upper aesthetic zone with a jumping gap < 2 mm.
surgically guided placement of a single immediate post-extraction implant in the upper esthetic zone with a jumping gap ≥ 2mm.
Time frame: Assessment at baseline and after 12 months.
It will be measured virtually using CBCT measurements, fusion of the C.B.C.Ts will be done.
Time frame: Before implant placement and immediately after.
A preliminary measurement of the jumping gap will be taken from the CBCT during implant planning and patient allocation either into the control or intervention group. These measurements will be done at the patient preparation phase and immediately post implant placement.
Time frame: Assessment at baseline, 3 months, 6 months, 9 months and 12 months.
It will be measured using periapical radiographs in parallel technique for standardization comparing different bone levels.
Time frame: Assessment after final crown delivery (baseline), 3 months, 6 months, 9 months and 12 months.
It will be measured in scale with numerical value. The Pink Esthetic Score (PES) as proposed by (Fürhauser et al., 2005) contains seven variables: distal papilla, mesial papilla, soft tissue contour, soft tissue level, deficiency of the alveolar process, and soft-tissue texture and color. Each variable was assessed with a 0-1-2 score, with 0 being the worst and 2 being the best.
Time frame: One time at 12 months after crown delivery.
It will be measured using a questionnaire at the end of the study. The questionnaire will be in a form of three questions:
Time frame: Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.
It will be measured using a periodontal probe.
Time frame: Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.
It will be measured using an anaesthetic needle with stopper + periodontal probe.
Cairo University
Other
Clinical and Radiographic Evaluation of Change in Labial Bone Thickness in Immediate Implant Placement In Maxillary Esthetic Zone Comparing a Jumping Gap of Less Than 2 mm to Equal or More Than 2 mm: A Non-randomized Clinical Trial
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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.
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