Cairo University
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT07483086
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. The main questions it aims to answer are:
Does vertical implant position below the crest of the bone lead to less marginal bone loss? Will it affect implant survival as well as quality of soft tissue, esthetics and patient satisfaction?
Participants will:
Have an implant placed at the bone level or 2 mm below the bone level Visit the clinic once every 3 months for checkups, radiographs, and readings
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics (Degidi et al., 2011).
With respect to the depth of insertion, implants can be placed at various levels in the bone, which affects the peri-implant tissues with the surrounding marginal bone. Therefore, placement of an implant in a deeper position with respect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to maintain the peri-implant soft and hard tissues in comparison with crestal placement, though this affirmation is subject to controversy (Pellicer-Chover et al., 2019).
Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Each patient will be examined to confirm meeting the eligibility criteria. A full medical and dental history will be taken, and proper oral examination will be performed. Then a pre-operative cone beam computed tomography (CBCT) will be taken to examine both the bucco-lingual bone dimension and bone height and to ensure that the area of interest is free of any pathological lesions.
All the steps will be explained in detail to each patient and an informed consent will be taken from the patient to agree on their enrolment in the clinical trial. Then the patient will be treated first by phase I therapy for periodontal treatment through conventional supragingival scaling and subgingival debridement. Then strict oral hygiene instructions will be given and patients will be reassessed after a period of 4 weeks. Reassessment of the case is to ensure absence of any signs of inflammation and presence of normal tissues before the surgical procedure.
Clinical photographs will be taken at baseline, during surgery and at 3, 6 and 12 months postoperatively.
The patients will be randomly assigned into two groups:
Intervention group: Patients receiving delayed implant placed 2 mm subcrestal with immediate temporization
Control group: Patients receiving delayed implant placed equicrestal with immediate temporization
Surgical procedure:
Control group: inserted at the same level of the alveolar bone crest with adequate primary stability.
Postoperative Care:
Postoperative medication:
Administration of:
Patient self-care instructions:
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
2 mm subcrestal placement
crestal level placement
Time frame: Assessment at baseline, 3 months post-operative, 6 months post-operative, 9 months post-operative and 12 months post-operative
measured linearly in mm by comparing periapical radiographs
Time frame: 0, 3, 6, 9, 12 months post-operative
Corono-apical distance measured from the incisal edge/cusp tip to the peri-implant soft tissue margin
Time frame: baseline, 3, 6, 9, 12 months post-operative
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and soft tissue texture, all using a 0-1-2 scoring system, 0 being the lowest and 2 the highest value. The maximum achievable PES is 14.
Time frame: baseline, 3, 6, 9, 12 months post-operative
Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until the needle contacts bone, at 3 different points. Three readings will be taken mid-buccally at three different levels; 2 mm, 4 mm and 6 mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a caliper.
Time frame: 12 months post-operative
A binary outcome, the definition of implant success was based on the clinical and radiographic criteria described by Buser et al. 1990; 1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading (Buser, Weber and Lang, 1990)
Time frame: 12 months post-operative
A 12-item questionnaire is self-reported by the patients after 12 months post-operative; six questions with scores from 1 to 10 with the poorest score (not very satisfied) being 0 and the optimum score (satisfied) 10. The other six questions are yes or no questions (Derks et al., 2014)
Time frame: baseline, 12 months post-operative
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the three measurements will be at three levels: the implant platform, 2 mm and 5 mm from the platform. (Koerich et al., 2016).
Time frame: baseline, 12 months post-operative
Vertical bone height will be measured. Measurement will be taken at the highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. The difference between pre- and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension (Wu et al. 2019).
Time frame: baseline, 12 months
The angle between the tangent line of the restoration at the most coronal point of the buccal mucosa and the implant long axis (Wang et al., 2022).
Cairo University
Other
The Influence of Vertical Implant Position With Immediate Temporization on Marginal Bone Loss in Cases With Thin Soft Tissue Phenotype: A Randomized Controlled 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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