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

NCT06207617 | Not Yet Recruiting DMC

• 1 other identifier: IDCE.N9
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Immediate Implants

Outcome Measures

Primary Outcomes (1)

• Bucco-lingual ridge dimension

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

  12 months

Secondary Outcomes (5)

• total buccal volume loss (mm3)

  12 months

• Horizontal labio-palatal bone width

  12 months

• Vertical crestal bone level changes

  12 months

• mid-facial recession

  12 months

• linear volumetric change of buccal soft tissue contour

  12 months

Study Arms (2)

Immediate implant placement + customized healing abutment

EXPERIMENTAL

After atraumatic extraction, flapless immediate implant of a suitable size will be placed using sequential drills of the Straumann implant system for osteotomy preparation. According to the prosthetically driven planned position, implant will be placed. Primary stability of the implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All patients will receive an immediate anatomical 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.

Procedure: Immediate implant placement + customized healing abutment

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

ACTIVE COMPARATOR

After atraumatic extraction, immediate implant will be placed as mentioned-above, then particulate xenogeneic bone graft will be packed into the gap between the implant and the buccal plate mesially and distally. bone grafting will be up to the level of the buccal bone crest, followed by screwing the customized healing abutment.

Procedure: Immediate implant placement + xenogeneic bone graft material + customized healing abutment

Interventions

Immediate implant placement + customized healing abutment PROCEDURE

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

Also known as: IIP+customized healing abutment

Immediate implant placement + customized healing abutment

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

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.

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Thin buccal plate of bone (1 mm or less) among both of the mesial and distal root, assessed by CBCT.
• Intact gingival tissue with at least 2 mm keratinized tissue.
• Patients accepts to provide written informed consent.

You may not qualify if:

• 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.
• Patients undergoing chemotherapy and/or radiotherapy.
• Presence of systemic disease that would affect wound healing.
• Presence of active infection with soft tissue communication.

Sponsors & Collaborators

• Misr International University: lead

Central Study Contacts

Nourhan Gamal

CONTACT

01064249441; nourhannegamal259@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Aboulfettouh

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share