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AzTrials

Immediate Implant Placement in Mandibular Molar Extraction SocketsRCTNCT07774052

Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Graft Versus Conventional Immediate Implant Placement With Xenograft

A study testing Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold and Conventional Immediate Implant Placement in people with Immediate Implant Placement in Mandibular Molar Extraction Sockets, run by Mahmoud Fawzy Mahmoud Mohamed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled clinical trial will evaluate a computer-guided immediate implant placement technique in non-restorable mandibular molars using a patient-specific 3D-printed polylactic acid (PLA) graft and implant position guide, compared with conventional immediate implant placement using xenograft for… Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold and Conventional Immediate Implant Placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteEgypt
Study dates
4 Nov 2024to 31 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients requiring immediate implant placement in mandibular molar extraction sockets.
  • Patients with adequate bone volume to accommodate the planned implant.
  • Patients willing to undergo immediate implant placement and follow-up for 6 months.
  • Patients who provided informed consent.

Who cannot join

  • Uncontrolled systemic diseases or medical conditions contraindicating implant surgery.
  • Patients receiving medications or treatments that may adversely affect bone healing.
  • smokers.
  • Poor oral hygiene or uncontrolled periodontal disease.
  • Acute uncontrolled infection at the surgical site.
  • Conditions requiring additional bone augmentation beyond the study protocol.
  • Patients unable or unwilling to attend the required follow-up visits.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Department of Oral & Maxillofacial Surgery , Faculty of Oral & Dental Medicine , Future University in Egypt

    New Cairo

Other trials in Egypt

About this study

This randomized controlled clinical trial will evaluate a computer-guided immediate implant placement technique in non-restorable mandibular molars using a patient-specific 3D-printed polylactic acid (PLA) graft and implant position guide, compared with conventional immediate implant placement using xenograft for grafting of the jumping gap.

Eligible patients requiring extraction and immediate implant placement in mandibular molars will be randomly allocated to either the PLA-guided intervention group or the conventional treatment group. In the intervention group, a patient-specific 3D-printed PLA graft and guide will be designed from preoperative CBCT data and used to guide implant placement in the digitally planned position. In the control group, immediate implant placement will be performed using the conventional protocol with xenograft grafting.

Read more

The study will assess the primary stability of the dental implant and the accuracy of implant placement compared with the digitally planned position. Implant stability will be measured using the Osstell device, while implant position will be evaluated by superimposing the immediate postoperative CBCT scan on the preoperative CBCT using Blue-Sky Plan software.

Patients will be followed clinically after surgery, with follow-up visits during the healing period and a six-month postoperative CBCT evaluation before implant loading.

Read the detailed description

This is a prospective randomized controlled clinical trial designed to evaluate computer-guided immediate implant placement in mandibular molar extraction sockets using a patient-specific 3D-printed polylactic acid (PLA) socket guide and customized root-form PLA graft, compared with conventional freehand immediate implant placement using xenograft.

Immediate implant placement in mandibular molar extraction sockets can be challenging because of the wide socket morphology and the limited amount of bone available for achieving primary implant stability. The interradicular septum and apical bone are important for implant anchorage, while the irregular shape of the extraction socket may make conventional freehand osteotomy preparation and implant positioning difficult.

In the experimental group, preoperative cone-beam computed tomography (CBCT) data will be used for three-dimensional digital planning of the implant position. The implant position, angulation, diameter, and length will be planned using Blue Sky Plan 4 software. A patient-specific socket-supported PLA surgical guide will then be designed according to the planned implant position. A customized root-form PLA graft will also be designed to fit the peri-implant gap within the extraction socket.

The PLA socket guide and customized PLA graft will be fabricated using additive manufacturing. The patient-specific guide will be used during osteotomy preparation to control the drilling trajectory and facilitate placement of the implant according to the digitally planned position. The customized PLA graft will be positioned within the residual gap between the implant and extraction socket walls.

Participants allocated to the control group will undergo conventional immediate implant placement using a freehand surgical technique. Xenograft will be used for grafting of the peri-implant gap according to the conventional treatment protocol.

All participants will undergo preoperative clinical and radiographic assessment. Clinical assessment includes medical and dental history, periodontal assessment, occlusal assessment, and plaque-control assessment. CBCT will be used to evaluate the extraction socket, root morphology, interradicular bone, and available bone dimensions before implant placement.

The primary outcomes of the study are implant primary stability and implant positional accuracy. Implant stability will be assessed using resonance frequency analysis/implant stability measurement at the time of implant placement and during follow-up. Implant positional accuracy will be assessed by comparing the virtually planned implant position with the actual postoperative implant position using CBCT-based evaluation. Positional accuracy will be assessed as a single positional accuracy outcome incorporating the measured deviations between the planned and actual implant position.

Participants will be followed clinically during the healing period, with assessment of implant stability at the planned follow-up period. A postoperative CBCT examination will be used to evaluate the actual implant position and compare it with the preoperative virtual plan.

The study is intended to determine whether the patient-specific 3D-printed PLA socket guide and customized PLA graft can improve primary implant stability and the accuracy of immediate implant placement compared with the conventional freehand technique using xenograft.

Being tested
Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold, Conventional Immediate Implant Placement
Keywords
immediate implant placement, mandibular molars, dental implants, primary implant stability, computer guided implant surgery, 3d printed PLA, patient specific surgical guide, root form graft, socket guide, implant positional accuracy, socket preservation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-Specific 3D-Printed PLA Socket Guide and Root-Form ScaffoldDevice

    A patient-specific 3D-printed polylactic acid (PLA) socket-supported surgical guide was used to guide implant osteotomy preparation, combined with a customized root-form PLA scaffold designed to occupy the residual peri-implant socket gap and provide structural support during immediate implant placement in mandibular molars.

  • Conventional Immediate Implant PlacementDevice

    Freehand immediate implant placement with particulate xenograft to fill the residual peri-implant socket gap.

Study groups in NCT07774052
Study groupRoleWhat they receive
PLA-Guided immediate implant placementExperimentalImmediate implant placement using a patient-specific 3D-printed PLA socket guide and customized root-form PLA scaffold
Receives: Device: Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold
Conventional Immediate Implant PlacementActive comparatorFreehand immediate implant placement with particulate xenograft to fill the residual peri-implant socket gap
Receives: Device: Conventional Immediate Implant Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant primary stability (IST)

    Primary implant stability was measured using resonance frequency analysis and expressed as an Implant Stability Quotient (IST) value.

    Measured: Immediately after implant placement

Secondary outcomes (2)
  1. Implant stability at 6 months (IST)

    Implant stability was assessed using resonance frequency analysis and expressed as an Implant Stability Quotient (IST) value.

    Measured: 6 months after implant placement

  2. Implant positional accuracy

    Implant positional accuracy was assessed by comparing the planned and actual implant positions using postoperative CBCT, including coronal, apical, and angular deviations.

    Measured: Immediately after implant placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start4 Nov 2024
  3. Primary completion31 May 2026
  4. Study completion31 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774052
Sponsor's protocol ID
FUE.REC (53)/11-2024
Acronym
RCT
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tümer EH, Erbil HY. Extrusion-based 3D printing applications of PLA composites: a review.

  • Rabel A, Kohler SG, Schmidt-Westhausen AM. Clinical study on the primary stability of two dental implant systems with resonance frequency analysis. Clin Oral Investig. 2007 Sep;11(3):257-65. doi: 10.1007/s00784-007-0115-2. Epub 2007 Mar 31.

    PubMed 17401588
  • Gopalakrishnan K, Chandrasekaran B, John RR. Comparison of accuracy of immediate implant placement between planned and actual position in pre-extractive versus conventional method - A prospective study. J Craniomaxillofac Surg. 2024 May;52(5):598-605. doi: 10.1016/j.jcms.2024.02.020. Epub 2024 Feb 12.

    PubMed 38378368
  • DeStefano V, Khan S, Tabada A. Applications of PLA in modern medicine. Eng Regen. 2020;1:76-87. doi: 10.1016/j.engreg.2020.08.002. Epub 2020 Sep 6.

    PubMed 38620328
  • Singhvi MS, Zinjarde SS, Gokhale DV. Polylactic acid: synthesis and biomedical applications. J Appl Microbiol. 2019 Dec;127(6):1612-1626. doi: 10.1111/jam.14290. Epub 2019 Jun 17.

    PubMed 31021482
  • Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.

    PubMed 18437791
  • Hallman M, Thor A. Bone substitutes and growth factors as an alternative/complement to autogenous bone for grafting in implant dentistry. Periodontol 2000. 2008;47:172-92. doi: 10.1111/j.1600-0757.2008.00251.x. No abstract available.

    PubMed 18412581
  • Ortega-Martinez J, Perez-Pascual T, Mareque-Bueno S, Hernandez-Alfaro F, Ferres-Padro E. Immediate implants following tooth extraction. A systematic review. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e251-61. doi: 10.4317/medoral.17469.

    PubMed 22143704
  • Verket A, Lyngstadaas SP, Tiainen H, Ronold HJ, Wohlfahrt JC. Impact of particulate deproteinized bovine bone mineral and porous titanium granules on early stability and osseointegration of dental implants in narrow marginal circumferential bone defects. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1086-1094. doi: 10.1016/j.ijom.2018.02.007. Epub 2018 Mar 20.

    PubMed 29571671
  • Meijer HJA, Raghoebar GM. Immediate implant placement in molar extraction sites: a 1-year prospective case series pilot study. Int J Implant Dent. 2020 Feb 12;6(1):3. doi: 10.1186/s40729-019-0201-7.

    PubMed 32048081
  • Sanz M, Lindhe J, Alcaraz J, Sanz-Sanchez I, Cecchinato D. The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial. Clin Oral Implants Res. 2017 Aug;28(8):902-910. doi: 10.1111/clr.12896. Epub 2016 Jun 7.

    PubMed 27273298
  • Valente F, Schiroli G, Sbrenna A. Accuracy of computer-aided oral implant surgery: a clinical and radiographic study. Int J Oral Maxillofac Implants. 2009 Mar-Apr;24(2):234-42.

    PubMed 19492638
  • Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.

    PubMed 31215112

Questions about this trial

What is this clinical trial studying?

A study testing Patient-Specific 3D-Printed PLA Socket Guide and Root-Form Scaffold and Conventional Immediate Implant Placement in people with Immediate Implant Placement in Mandibular Molar Extraction Sockets, run by Mahmoud Fawzy Mahmoud Mohamed at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant primary stability (IST) (time frame: Immediately after implant placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774052, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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