Dimensional Changes Following Immediate Implant Placement in Molar Extraction Sockets With or Without Bone Graft

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMisr International University

About this trial

Statement of problem: The majority of studies on immediate implant placement are related to the maxillary esthetic zone. Literature concerning Immediate implant placement in the posterior region is scarce. Furthermore, there is paucity of evidence on alveolar bone dimensional changes following immediate implant placement in fresh extraction sockets of posterior teeth. Adding to that, negligible evidence is known about the soft tissue alterations which take place during modeling and remodeling phases of socket healing process; regarding the molar sites. Nevertheless, Immediate installation into a molar socket raises an extra challenge for the clinicians, because of the different anatomical features of the extraction sockets compared to that of the single-rooted teeth in the anterior zone. In addition to, implant positioning difficulties; due to the amount of the residual inter-radicular bone after extraction. Aim of the study: To assess the bucco-lingual ridge collapse after immediate implant placement in lower 1st molar sites either with customized healing abutment only; or with xenogeneic bone graft and customized healing abutment. Materials and methods: The current study will include 28 non-restorable lower 1st molar teeth indicated for extraction in the posterior area. Patients will randomly be assigned into two equal groups: the test group; Immediate implant placement + customized healing abutment group and the control group; Immediate implant placement +bone graft+ customized healing abutment group. The presented trial will investigate the following outcomes: bucco-lingual ridge collapse as the primary outcome, together with mid-facial recession, total volume gain/loss, buccal soft tissue contour, bucco-lingual bone width, and vertical bone changes as the secondary outcomes after 12 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults from the age of 18 - 50 years of both genders.

Patients with non-restorable single bounded mandibular 1st molar tooth indicated for extraction.

Periodontally healthy patients with good oral hygiene.

Intact interradicular bone with 2-3 mm width, assessed by CBCT.

Disqualifiers

Molar sites indicated for extraction with roots of close proximity to vital structures as inferior alveolar nerve.

Pregnant females.

Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).

Handicapped and mentally retarded patients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate implant placement + customized healing abutment

    Procedure/Surgery

    Immediate implant placement in fresh extraction molar sites + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. no grafting material included in this arm

  • Immediate implant placement + xenogeneic bone graft material + customized healing abutment

    Procedure/Surgery

    Immediate implant placement in fresh extraction molar sites + xenogenic bone graft + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Immediate implant placement + customized healing abutmentExperimental treatment 1 intervention
Group B: Immediate implant placement + xenogeneic bone graft material + customized healing abutmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bucco-lingual ridge dimension

volumetric analysis software will calculate the overall labio-palatal ridge width (mm)

Time frame
12 months

Secondary outcomes

1

total buccal volume loss (mm3)

volumetric analysis software will calculate the overall labio-palatal ridge width (mm)

Time frame
12 months
2

Horizontal labio-palatal bone width

A reference line will be constructed along the palatal surface of the implant on the cross-sectional cut of the postoperative CBCT volume. Then, both initial (T0) and postoperative (T1) CBCT volumes will be superimposed on the fusion module. The horizontal labio-palatal width will be measured from the reference line to the outer labial bone at three levels below the labial bone crest: 0mm, 2mm and 5mm at T0 and T1. The difference between T1 and T0 will be calculated and compared to record the mm and % horizontal labio-palatal bone collapse.

Time frame
12 months
3

Vertical crestal bone level changes

a horizontal line will be placed to mark the crestal labial bone on both the initial and postoperative CBCT volumes separately. Then, both initial and postoperative CBCT volumes will be superimposed on the fusion module. A vertical linear measurement perpendicular to both lines will be done to record the mm vertical crestal bone level changes.

Time frame
12 months
4

mid-facial recession

using a volumetric analysis software

Time frame
12 months

Other outcomes

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