NCT06195761

Brief Summary

To assess the accuracy of the computer assessed guides in horizontal bone augmentation achieved at posterior mandible using guided modified ridge splitting technique versus free hand modified ridge splitting technique

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
2.4 years until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

December 23, 2023

Last Update Submit

January 15, 2026

Conditions

Keywords

computer guided modified ridge splittingcomputer guided modified cortical shell techniqueguided modified ridge splitting in posterior mandible

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the Computer Assessed Guide in the study group

    Accuracy of the Computer Assessed Guide in the study group In comparison with the control group between predicted and immediately postoperative horizontal bone width with Cone beam computed tomography in Millimeters measurement tool is CBCT scan superimposition in mm

    immediately postoperative

Secondary Outcomes (1)

  • Alveolar ridge horizontal bone gain

    4 months

Other Outcomes (1)

  • soft tissue dehiscience

    2 months postoperatively

Study Arms (2)

computer guided modified ridge splitting technique (study group)

EXPERIMENTAL

The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.

Procedure: computer guided modified ridge splitting technique in horizontal bone deficiency in posterior mandible

conventional modified ridge splitting technique (control group)

EXPERIMENTAL

The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide

Procedure: free hand modified ridge splitting technique in horizontal bone deficiency in posterior mandible

Interventions

treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide

Also known as: computer guided modified cortical shell technique
computer guided modified ridge splitting technique (study group)

treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.

Also known as: conventional modified cortical shell technique
conventional modified ridge splitting technique (control group)

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • posterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually
  • Age range from 25-55 years. No sex predilection.
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • Patients of adequate alveolar bone width.
  • Both genders males and females will be included
  • Normal vertical dimension with normal inter-arch space. The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent anterior teeth

You may not qualify if:

  • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
  • Previous grafting procedures in the edentulous area.
  • General contraindications to implant surgery.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Immunosuppressed or immunocompromised
  • Heavy smokers
  • Patients undergo medication interfere with bone healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Manial, 12613, Egypt

Location

Related Publications (5)

  • Al-Ani O, Nambiar P, Ha KO, Ngeow WC. Safe zone for bone harvesting from the interforaminal region of the mandible. Clin Oral Implants Res. 2013 Aug;24 Suppl A100:115-21. doi: 10.1111/j.1600-0501.2011.02393.x. Epub 2012 Jan 11.

  • Sanchez-Labrador L, Molinero-Mourelle P, Perez-Gonzalez F, Saez-Alcaide LM, Brinkmann JC, Martinez JL, Martinez-Gonzalez JM. Clinical performance of alveolar ridge augmentation with xenogeneic bone block grafts versus autogenous bone block grafts. A systematic review. J Stomatol Oral Maxillofac Surg. 2021 Jun;122(3):293-302. doi: 10.1016/j.jormas.2020.10.009. Epub 2020 Nov 5.

  • De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.

  • Schwartz-Arad D, Levin L, Sigal L. Surgical success of intraoral autogenous block onlay bone grafting for alveolar ridge augmentation. Implant Dent. 2005 Jun;14(2):131-8. doi: 10.1097/01.id.0000165031.33190.0d.

  • Assaf A, Saad M, Daas M, Abdallah J, Abdallah R. Use of narrow-diameter implants in the posterior jaw: a systematic review. Implant Dent. 2015 Jun;24(3):294-306. doi: 10.1097/ID.0000000000000238.

Study Officials

  • Mohamed Mounir Shaker, BDS,MSc,PHD

    Cairo University

    STUDY CHAIR
  • Rofaida Atef Abaas, BDS,MSc,PHD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mina ElHadidi Sobhi Ramzi, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2023

First Posted

January 8, 2024

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations