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NCT Number: NCT07238738

Comparison Between Modified Periosteal Inhibition (MPI) and Flapless Immediate Implant Placement

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.

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Key information

Conditions

Non-restorable Posterior Teeth Buccal Bone Fenestraion Thin Buccal Bone Plate

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura university

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's age ranges between 20 and 50 years including both genders.
  • General good health (American Society of Anesthesiologists I-II).
  • Presence of one hopeless non-restorable tooth requiring extraction at the posterior region.
  • Adequate amount of palatal bone and basal bone (≥ 3 mm) to engage the immediately placed implants.
  • Adequate keratinized soft tissue.
  • Thick gingival phenotype (˃ 1.5 mm).
  • Thin buccal bone plate or presence of fenestration.
  • Favorable pattern of occlusion.
  • Patient who is able to understand and sign a written consent.

Exclusion criteria

  • Pregnancy or lactating females.
  • Untreated periodontitis.
  • Acute dentoalveolar infection.
  • Complete absence of buccal bone plate.
  • Osteometabolic disease.
  • Chemotherapy or radiation therapy history of the neck-head area within the past 12 months.
  • Heavy smokers (>20 cigarettes/per day) according to WHO.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT).

    Time frame: Baseline, 6 months, 12 months after the implant placement

    • Marginal Bone Level Measurements: It is the distance between a fixed reference point and the most apical point of connection between the implant surface and the bone. The reference point is the fixture-abutment interface.
    • Bucco-lingual Alveolar Width: Width measurements will be made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest at 1, 3 and 6 mm from summit of the alveolar crest.

Secondary outcomes

  1. Pain Index

    Time frame: first post-operative day, third day and after one week.

    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.

  2. Wound Healing Index (WHI)

    Time frame: 1 and 2 weeks after surgery

    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.

  3. Implant Stability Measurements

    Time frame: The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase.

    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.

  4. Peri-implant Probing Depth (PPD)

    Time frame: Baseline, 6 months and 12 months post-operatively.

    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.

  5. Esthetic Evaluation

    Time frame: At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meran F Awad, MSc

CONTACT

[email protected]

+201022216881

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Impact of Modified Periosteal Inhibition Technique on Alveolar Bone Stability in Immediate Implant Placement Procedures (Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.