Modified Periosteal Inhibition with Simultaneous Implant Placement in Aesthetic Zone
ConditionImmediate Dental Implant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTanta University
About this trial
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 0.5 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Intact labial plate of bone with thickness ≤1 mm (Socket type I).
Moderate to thick gingival phenotype.
Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
Presence of at least 3 mm of keratinized gingiva.
Disqualifiers
Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
Pregnant or lactating women.
Smoking
Absence of buccal plate of bone.
Trial design
Design model
Parallel
Treatments tested in this trial
Modified periosteal inhibition
Procedure/SurgeryAfter local anathesia, 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 soft bone lamina 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. Then the jumping gap between the dental implant and the buccal plate of bone will be filled using either collagen sponge or xenograft.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Collagen sponge group :Sham comparator 1 intervention
Group B: Bone graft group:Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
baseline, 6 and 12 months after implant placement.Secondary outcomes
1
Implant stability
The implant stability: it will be measured using the Resonance Frequency Analysis Device.
Time frame
baseline and 6 months after implant placement.2
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.
Time frame
within one week after surgery, 1 month and 6 months3
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.
Time frame
immediately after final prosthetic delivery and 6 months later.4
Digital Assessment
Each group will be subjected to intraoral scanning at baseline, 6 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.
Time frame
baseline, 6 and 12 months.Sponsors and contacts
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Source ClinicalTrials.gov