Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh

Mandible Small Clinical Trial

— RCT  

Official title:

Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017117
• Other study ID #: CEBD-CU-2019-06-19
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Adham Y Zakaria, Master
• Phone: 00201226000564
• Email: amira_5queens[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.

Description:

Designing and manufacturing

1. The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.

2. The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.

3. After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.

4. It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.

5. Thereafter the sheet was placed in an autoclave and sterilized using a standard program.

6. The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery

1. The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.

2. Local anesthesia is administered.

3. Horizontal crestal incisions are made lingual of the mid-crest within the keratinized tissue. Vertical releasing incisions are placed on the buccal aspect of the surgical site in the usual manner to provide adequate access and to allow for eventual coronal repositioning.

4. Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.

5. The cortex of the mandibular crest is generously perforated to produce bleeding in multiple sites. The pilot holes for the fixation screws were also prepared at this time.

6. The barrier is inserted over the mandible and compressed into place, the fixation screws are inserted and no adaptation will be needed as the barrier is custom-made for the edentulous ridge.

7. The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.

8. After fixation of the sheets, the buccal flaps should be coronally repositioned.

9. Split-thickness periosteal releasing incisions are completed to aid in primary tension-free closure. The flap margins are then advanced over the barrier and approximated to evaluate for tension-free closure.

10. After a mean of 6 months of uneventful healing, the augmented sites are reopened. The ceramic barrier and fixation screws are identified and removed, followed by Dental implant.

Post-operative care:

Avoid traumatization of the surgical site. Patients must abstain from brushing at the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).

Instruct the patient not to touch or manipulate the surgical area. Ice packs for 10 minutes every 30 minutes for 24 hours. Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.

No consume of tobacco

Post-operative medications will be prescribed as follows:

Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate 0.1% mouthwash 3 times daily for 14 days.

11b. Criteria for discontinuing or modifying intervention: No protocol for discontinuation of the procedure. 11c. Strategies to improve adherence to intervention: Face to face adherence reminder session will take place to stress on the post-operative instructions at the following time intervals.

Patients were recalled every other day to monitor soft tissue healing for the first week, one visit weekly for the first month then monthly for 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 1, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients with atrophic posterior mandible

2. Both sexes

3. No intraoral soft and hard tissue pathology

4. No systemic condition that contraindicate implant placement

Exclusion Criteria:

1. Untreated gingivitis, periodontitis

2. Insufficient oral hygiene

3. Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.

4. Systemic disorders

5. Heavy smoking more than 20 cigarettes per day

6. Bone pathology

7. Psychiatric problems

8. Emotional instability

9. Unrealistic aesthetic demands

Related Conditions & MeSH terms

• Mandible Small
• Micrognathism

Intervention

Procedure:
• under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
comparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute.

Locations

Country	Name	City	State
Egypt	Faculty Of Dental and Oral Medicine-Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Her S, Kang T, Fien MJ. Titanium mesh as an alternative to a membrane for ridge augmentation. J Oral Maxillofac Surg. 2012 Apr;70(4):803-10. doi: 10.1016/j.joms.2011.11.017. Epub 2012 Jan 28. — View Citation

Misch CM. Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):581-9. — View Citation

Pieri F, Corinaldesi G, Fini M, Aldini NN, Giardino R, Marchetti C. Alveolar ridge augmentation with titanium mesh and a combination of autogenous bone and anorganic bovine bone: a 2-year prospective study. J Periodontol. 2008 Nov;79(11):2093-103. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).	Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography	6 months
Secondary	Rate of Soft Tissue Dehiscence	which mesh will cause soft tissue dehiscence more.	6 months

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