"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement

NCT07108361 | Not Yet Recruiting

• 1 other identifier: FDASU-REC ID052505
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Also, the alveolar ridge undergoes various remodeling processes following tooth extraction, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation. Immediate implant placement help preserve the alveolar ridge dimensions and buccal ridge contour. While osseodensification has shown promise in enhancing primary stability and bone microarchitecture, its clinical and microstructural effects in molar extraction sockets remain underexplored. Although there is ample documentation of information on the temperature that is generated during preparation of implant sites, there are no studies available in the literature comparing conventional drilling and osseodensification techniques; therefore, the present investigation was aimed at analyzing the efficacy of osseodensification compared to conventional drilling in terms of bone dimensions preservation , changes in bone architecture during implant site preparation and heat generation to define which technique can be safely applied to achieve the necessary implant primary stability without damaging the surrounding bone. Aim of the study: Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation

Conditions

Implant Osseointegration; Implant Osteotomy; Implant Placement; Implant Primary Stability; Molar Extraction Socket; Immediate Implant Placement

Keywords

non restorable tooth; molar extraction; multirooted teeth; extraction socket; immediate Implant placement; Osseodensification; ex-vivo; RCT; Jumping gap; Grafting

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols

  Septum width will be directly measured post molar extraction. Measurement will be recorded at the narrowest width of the septum Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation

  from enrollment to the day of surgery

Secondary Outcomes (7)

• Comparing of bony Micro-architecture following osseodensification and conventional drilling protocols.

  Day of surgery

• Comparing amount of heat generation following osseodensification and conventional drilling protocols.

  from enrollment to the day of surgery

• Assessment of the clinical outcomes of implant placement in the extraction socket comparing the two drilling protocols

  All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)

• Radiographic assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols

  All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)

• > Volumetric assessment of the ridge buccal contour following implant placement with and without grafting the jumping gap.

  All parameters will be assessed preoperative, six months (T6) and 12 months (T12)

Study Arms (2)

conventional drilling group

ACTIVE COMPARATOR

Procedure: conventional drilling

Osseodensification group

EXPERIMENTAL

Procedure: Osseodensification

Interventions

Osseodensification PROCEDURE

Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. Implant site preparation starts with a pilot drill, in clockwise motion, in the center of the septum, until 1 mm deeper than the planned implant length. Densah® Burs (Versah, LLC, Jackson, MI, USA) were then sequentially used in OD mode (counterclockwise, drilling speed 800-1500 rpm, with copious irrigation) in small increments to gradually expand the osteotomy, until reaching the desired width for the planned implant diameter, Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket, insertion torque will be measured using the torque wrench and ISQ values

Osseodensification group

conventional drilling PROCEDURE

Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. The initial (pointed) drill will be used to make a hole (starting point) in the interradicular bone to avoid slippage of the subsequent the drills in the socket of the remaining roots. The drills of increasing diameters will be used to complete the implant osteotomy according to manufacturer instructions. In case of limited interradicular bone volume, drilling will be made at the socket of mesial or distal roots. Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket insertion torque will be measured using the torque wrench and ISQ values

conventional drilling group

Eligibility Criteria

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

You may qualify if:

• Patients requiring placement in the posterior region.
• ASA I and II patients who can undergo immediate implant placement and restorative procedures.
• Both males and females.
• Patient's age: 18-50 years old.
• Patients who can come for the follow-up visit.
• Patients who provide written informed consent

You may not qualify if:

• Pregnancy.
• Smoking
• Patients with previously failed dental implants at the implant placement site.
• Patients with active infections.
• Other medical conditions that might affect the osseointegration of dental implants, such as diabetes, cardiovascular disease, hypertension, and osteoporosis

Sponsors & Collaborators

• Ain Shams University: lead
• Augusta University: collaborator

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Central Study Contacts

Mohammed Samir

CONTACT

01144063175; mohamedsamirramardan@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)