About this trial
This randomized clinical trial aims to evaluate labial bone plate changes following immediate implant placement in Type II extraction sockets using two different xenograft materials and de-epithelialized free gingival graft in the esthetic zone . Patients requiring extraction and immediate implant placement will be randomly allocated into two groups according to the xenograft material used for defect grafting. Clinical and radiographic outcomes will be assessed to determine dimensional bone changes and implant success
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with one or more non-restorable teeth or remaining roots without signs of acute infection in the maxillary anterior region.
Type II extraction sockets.
Sufficient bone (>3 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥ 30 N cm).
Good compliance.
Disqualifiers
Teeth with current acute periapical infection.
Medically compromised patients.
Heavy smokers (smoking of more than 10 cigarettes per day ).
Alcohol or drug abuse.
Trial design
Parallel
Treatments tested in this trial
Immediate Implant Placement with Medpark S1 xenograft
Procedure/SurgeryImmediate implant placement in Type II extraction sockets, with gap grafting using Medpark S1 xenograft .
Immediate Implant Placement with bio-Oss xenograft
Procedure/SurgeryImmediate implant placement in Type II extraction sockets, with gap grafting using bio-Oss xenograft
Treatment groups
Trial outcomes
Primary outcomes
Labial Bone Plate Thickness Change
Dimensional changes of the labial alveolar bone plate will be measured using standardized CBCT images to assess the effectiveness of the two xenograft materials in preserving bone contour
Secondary outcomes
Peri-implant mucosal level (PML)
Intraoral scanning will be performed preoperative, immediate postoperative (baseline) and six months postoperatively. The 3D software will be used to align the baseline and six month models using the best-fit algorithm of the software to perfect the superimposition process. The superimposed models will be assessed using specific software, where the measurements will be performed to compare soft tissue outcomes between the two xenograft materials
Other outcomes
Clinical assessment of Pink Esthetic score
Seven variables will be scored: mesial papilla, distal papilla, to curvature of the facial mucosa, level of the facial mucosa and soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter obtain a final score of 14 minimum score 0,maximum score 14 higher score means better
Sponsors and contacts
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Basma Gamal Mohamed Ahmed
Lead sponsor
Alexandria University
Sponsor institution