Clinical trial NCT06195761: Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Horizontal Bone Augmentation
Horizontal Ridge Deficiency
Keywords: computer guided modified ridge splitting
computer guided modified cortical shell technique
guided modified ridge splitting in posterior mandible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the Computer Assessed Guide in the study group
timeFrame: immediately postoperative
Secondary outcomes:
measure: Alveolar ridge horizontal bone gain
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Mohamed Mounir Shaker, BDS,MSc,PHD
role: STUDY_CHAIR
affiliation: Cairo University
name: Rofaida Atef Abaas, BDS,MSc,PHD
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.
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.
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.
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.