Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible

Horizontal Ridge Deficiency Clinical Trial

Official title:

Radiographic Assessment of Computer Guided Modified Ridge Splitting Technique Versus Conventional Free Hand Technique in Management of Horizontal Deficiency in Posterior Mandible: a Randomized Control Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195761
• Other study ID #: computer guided modified ridge
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Mina ElHadidi Sobhi Ramzi, BDS
• Phone: +201225339712
• Email: mina.ramzi[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide. The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Horizontal Bone Augmentation
• Horizontal Ridge Deficiency

Intervention

Procedure:
• computer guided modified ridge splitting technique in horizontal bone deficiency in posterior mandible
treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide
• free hand modified ridge splitting technique in horizontal bone deficiency in posterior mandible
treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Cairo University	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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 syste — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately postoperative
Secondary	Alveolar ridge horizontal bone gain	measure the amount of horizontal bone width gaining by postoperative cone beam computed tomography in millimeters	4 months