Clinical trial NCT06519773: Modified Periosteal Inhibition with Simultaneous Implant Placement in Aesthetic Zone
Official title: Modified Periosteal Inhibition Utilizing Bone Graft Versus Collagen Sponge with Simultaneous Implant Placement in Aesthetic Zone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Immediate Dental Implant
Keywords: Immediate implant
Modified periosteal inhibition
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: A randomized controlled clinical and radiographic trial. The purpose of the present study will be explained to the patients and informed consents will be obtained according to guidelines adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University. 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. Twenty surgical sites will be divided into two groups; each of which has ten surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE).

1. Phase I therapy

   * Full mouth supra and subgingival scaling and root planing will be performed to all enrolled patients. Patients will be instructed to rinse twice daily with 0.12% chlorohexidine mouth wash for 2 weeks.
   * Before tooth extraction, initial radiographic records by cone beam computed tomography (CBCT) scans of the maxillary arch will be made. The pre-extraction measurements will be taken from CBCT scans to evaluate the presence of a fully intact labial plate of bone ≤1 mm. The labial plate thickness of the tooth to be extracted will be measured on cross sectional cuts at three levels below the labial bone crest: 0, 2, and 5 mm.
2. Surgical technique:

   * After 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 provided by Bego 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 provided by osteobiol 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. The cortical lamina will be fixed using Glubran 2 provided by GEM which is N-butyl 2 cyanoacrylate + Metacryloxysulfolane adhesive.

   The labial gap will be filled either with bone graft ( Regeinoss cortico cancelleous granules with collagen- xenograft. GRANNTIE )or collagen sponge.

   The socket orifice will be sealed using a customized healing abutment screwed to the implant, adequately finished, and polished to ensure a proper soft tissue emergence profile. The papilla will be sutured back using 5.0 polypropylene sling suture. For all cases, the sutures will be removed after 2 weeks.
3. Postoperative Phase -All subjects will receive postoperative instructions including:

   * Rinsing with 0.1% Chlorhexidine mouth rinse twice daily for two weeks.
   * Antibiotics combination of 500 mg Metronidazole along with Amoxicillin Clavulanate (Augmentin 1g) every 12 hours one day preoperatively and continuing for 5 days after extraction.
   * Non-steroidal anti-inflammatory (NSAID) medication of Ibuprofen 400 mg twice daily for one week.

Eligibility criteria: Inclusion Criteria:

1. Intact labial plate of bone with thickness ≤1 mm (Socket type I).
2. Moderate to thick gingival phenotype.
3. Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
4. Presence of at least 3 mm of keratinized gingiva.
5. Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria:

1. Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
2. Pregnant or lactating women.
3. Smoking
4. Absence of buccal plate of bone.
5. History of chemotherapy, radiotherapy in head and/or neck region.
6. Bisphosphonate therapy.

Primary outcomes:
measure: Radiographic cone beam computed tomography (CBCT) assessment
timeFrame: baseline, 6 and 12 months after implant placement.
Secondary outcomes:
measure: Implant stability
timeFrame: baseline and 6 months after implant placement.
measure: Soft tissue healing
timeFrame: within one week after surgery, 1 month and 6 months
measure: The esthetic
timeFrame: immediately after final prosthetic delivery and 6 months later.
measure: Digital Assessment
timeFrame: baseline, 6 and 12 months.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: ElGharbiya
Study officials:
affiliation: Tanta University
name: Ghadeer Elbagoory, Msc
role: STUDY_CHAIR
References: