Modified Periosteal Inhibition with Simultaneous Implant Placement in Aesthetic Zone

NCT06519773 | Recruiting Phase 1

• 1 other identifier: OMPDR 4-24 2191
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Immediate Dental Implant

Keywords

Immediate implant; Modified periosteal inhibition

Outcome Measures

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

  baseline, 6 and 12 months after implant placement.

Secondary Outcomes (4)

• Implant stability

  baseline and 6 months after implant placement.

• Soft tissue healing

  within one week after surgery, 1 month and 6 months

• The esthetic

  immediately after final prosthetic delivery and 6 months later.

• Digital Assessment

  baseline, 6 and 12 months.

Study Arms (2)

Collagen sponge group :

SHAM COMPARATOR

ten sites will be treated by MPI technique+ cortical lamina membrane and collagen sponge. The jumping gap between implant and buccal plate of bone will be filled with collagen sponge.

Procedure: Modified periosteal inhibition

Bone graft group:

ACTIVE COMPARATOR

ten sites will be treated by MPI technique +cortical lamina membrane and xenograft collagen. The jumping gap between implant and buccal plate of bone will be filled with xenograft collagen.

Procedure: Modified periosteal inhibition

Interventions

Modified periosteal inhibition PROCEDURE

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 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.

Bone graft group:; Collagen sponge group :

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

ElGharbiya

Tanta, Egypt

RECRUITING

Study Officials

• Ghadeer Elbagoory, Msc

  Tanta University

  STUDY CHAIR

Central Study Contacts

Ghadeer Elbagoory, Msc

CONTACT

00201118851277; ghadeer_elbagoory@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate lecturer

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)