Modified Periosteal Inhibition With Simultaneous Implant Placement in Aesthetic Zone
NCT Number: NCT06519773
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Immediate Dental Implant
Interventions: PROCEDURE: Modified periosteal inhibition
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-10-01
Locations: ElGharbiya, Tanta, Egypt

Summary:
A randomized controlled clinical and radiographic trial. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. These sites will be divided into two groups; each of which has ten surgical sites. After phase I therapy, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.

* Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
* After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A bone lamina 1 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone.

Primary Outcome Measures: Radiographic cone beam computed tomography (CBCT) assessment, The primary outcome of the study is to assess the amount of bone formed labial to the implant on the CBCT. This will be made by measuring bone thickness at the bone crest, 2mm and 5 mm above the crest, baseline, 3 and 12 months after loading.
Secondary Outcome Measures: Implant stability, The implant stability: it will be measured using the Resonance Frequency Analysis Device., baseline and 3 months after implant placement.|Soft tissue healing, it will be recorded according to soft tissue healing index Score Clinical finding Very poor • Tissue colour: ≥50% of gingiva red

* Response to palpation: Bleeding.
* Granulation tissue: Present
* Incision margin: Not epithelialized, with loss of epithelium beyond incision margin.
* Suppuration: Present. Poor • Tissue colour: ≥50% of gingiva red.
* Response to palpation: Bleeding.
* Granulation tissue: Present.
* Incision margin: Not epithelialized, with connective tissue exposed Good • Tissue colour: ≥25% and\<50% of gingiva red
* Response to palpation: No bleeding.
* Granulation tissue: None
* Incision margin: No connective tissue exposed. Very good • Tissue colour: \<25% of gingiva red.
* Response to palpation: No bleeding.
* Granulation tissue: None
* Incision margin: No connective tissue exposed. Excellent • Tissue colour: All tissues pink.
* Response to palpation: No bleeding.
* Granulation tissue: None
* Incision margin: No connective tissue exposed., within one week after surgery, 1 month and 3 months|The esthetic, it will be evaluated by pink esthetic score (PES) Variables 0 1 2 Mesial papilla Shape vs. reference tooth Absent Incomplete Complete Distal papilla Shape vs. reference tooth Absent Incomplete Complete Level of soft-tissue margin Level vs. reference tooth Major discrepancy \> 2mm Minor discrepancy 1-2 mm No discrepancy \< 1mm Soft-tissue contour Natural, matching reference tooth Unnatural Fairly natural Natural Alveolar process Alveolar process deficiency Obvious Slight None Soft-tissue color Color vs. reference tooth Obvious difference Moderate difference No difference Soft-tissue texture Texture vs. reference tooth Obvious difference Moderate difference No difference

* Each variable will take a score from: 2-1-0, with 2 being the best and 0 being the poorest score.
* The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth is 14 for all the seven parameters., immediately after final prosthetic delivery and 12 months later.|Digital Assessment, Each group will be subjected to intraoral scanning at baseline, 3 and 12 months. After loading The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the vertical and horizontal linear measurement of the mucosa calculated by software., baseline, 3 and 12 months.