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To clinically and radiographically assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement, on alveolar bone dimensional changes, in comparison to the conventional flapless immediate implant approach.
To assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement in comparison to the conventional flapless immediate implant approach on radiographically by assessing marginal bone level measurements and bucco-lingual alveolar width. Clinically, pain levels, wound healing index, primary, secondary implant stability measured by resonance frequency analysis (RFA), peri-implant probing depth, and pink esthetic score (PES) will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flapless immediate implant placement with cortico-cancellous bone allograft in the gap distance | Experimental | Participants receive immediately inserted implant via flapless approach with the grafting of cortico-cancellous bone allograft in the gap distance between dental implant and surrounding native alveolar bone followed by insertion of customized healing abutment. |
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| Immediate implant placement with MPI technique using collagen sponge in gap distance | Experimental | Participants receive immediately inserted implant in conjunction with modified periosteal inhibition technique (MPI) after flap reflection from the buccal side and fixation of a 0.5 mm-thick cortical lamina glued to the buccal cortex with cyanoacrylate material. Collagen sponge will be filled in the gap distance followed by insertion of customized healing abutment. |
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| Immediate implant with MPI technique using cortico-cancellous bone allograft in gap distance | Experimental | Participants receive immediately inserted implant in conjunction with MPI technique as described in group 2, however, cortico-cancellous bone allograft will be placed in the gap distance instead of collagen sponge and followed by insertion of customized healing abutment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate implant placement via flapless approach | Procedure | Implant site preparation will be performed flapless using 3D computer assisted planned surgical stent. Implant site preparation will be performed using commercially available standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. Cortico-cancellous bone allograft will be inserted inside the extraction socket in the gap distance between the implant and surrounding alveolar bone of the fresh extraction socket. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT). |
| Baseline, 6 months, 12 months after the implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Index | It will be evaluated using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes. | first post-operative day, third day and after one week. |
| Wound Healing Index (WHI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meran F Awad, MSc | Contact | +201022216881 | meran248@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meran F Awad, MSc | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura university | Al Mansurah | Egypt |
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| Immediate implant placement in conjunction with modified periosteal inhibition technique using collagen sponge in the gap distance | Procedure | After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that would allow the insertion of the cortical lamina. Cortical Lamina (0.5 mm thick) will be left in saline solution for 5 minutes and then cut to the desired shape, ranging from 8 to 10 mm in height, extending up to the mesial and distal margins of the extraction socket, molded until perfect fit and glued with two or three drops of N-butyl cyanoacrylate. A collagen sponge will be inserted inside the extraction socket to stabilize the clot. Suturing the papillae using 5-0 polypropylene monofilament. |
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| Immediate implant placement in conjunction with modified periosteal inhibition technique using cortico-cancellous bone allograft in the gap distance | Procedure | After papillae incisions, an intra-sulcular incision will be made on the vestibular side of the extraction socket, extending to the mesial and distal mid-tooth with a #15c surgical scalpel. Implant site preparation will be performed using 3D computer assisted planned surgical stent. Implant site preparation will be performed using a standard surgical kit. A single customized screw-type healing abutment will be screwed to the implant. A full-thickness flap will be elevated creating a room that would allow the insertion of the cortical lamina. Cortical Lamina (0.5 mm thick) will be left in saline solution for 5 minutes and then cut to the desired shape, ranging from 8 to 10 mm in height, extending up to the mesial and distal margins of the extraction socket, molded until perfect fit and glued with two or three drops of N-butyl cyanoacrylate. cortico-cancellous bone allograft will be inserted in the gap distance. Suturing the papillae using 5-0 polypropylene monofilament. |
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score 1 indicates uneventful healing with no gingival edema, erythema suppuration, patient discomfort or flap dehiscence. Score 2 indicates uneventful healing with slight gingival edema, erythema, patient discomfort or flap dehiscence, but no suppuration. While score 3 indicates poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration. |
| 1 and 2 weeks after surgery |
| Implant Stability Measurements | The stability of the implant will be evaluated with resonance frequency analysis (RFA). The measurements will be made with the Osstell device by connecting the transducer (smart peg) to the fixture. The mesiodistal and buccolingual direction will be measured and the mean implant stability quotient will be determined. | The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase. |
| Peri-implant Probing Depth (PPD) | Using a calibrated plastic periodontal probe, the distance between marginal border of the gingiva and the tip of the probe will be measured in mm. | Baseline, 6 months and 12 months post-operatively. |
| Esthetic Evaluation | Esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven variables will be scored; mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process deficiency, soft tissue color, and texture of facial gingiva at the implant site. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters. | At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively |