Transforming Channel Osteotomy Into Tunnel Osteotomy in Zygomatic Implant Preparation

ConditionZygomatic Implants

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorFayoum University

About this trial

The evolution of zygomatic implant techniques, from the original procedures to the Zygomatic Anatomy-Guided Approach (ZAGA), has significantly improved outcomes for patients with severe maxillary atrophy. Despite these advancements, challenges such as peri-implant tissue recession, sinus complications, and aesthetic concerns persist. Bone augmentation and soft tissue enhancement techniques, including sinus lifts, connective tissue grafts, and buccal fat pad utilization, have been employed to address these issues with varying degrees of success. However, the need for predictable and stable bone regeneration and soft tissue contouring remains critical for long-term implant success.

The following study aims to assess bone gain, soft tissue contour, and stability after using bone lamina shell, providing a potential solution to enhance peri-implant tissue integrity and optimize functional and aesthetic outcomes in zygomatic implant rehabilitation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Group A
Procedure/Surgery
after zygomatic implant placed with channel shape osteotomy,Wetting, trimming and fixation of xenogenic lamina shell buccal to placed zygomatic implants in combination with xenogenic particulate form to fill all gaps between lamina from one side and native bone and implant from other side
Group B
Procedure/Surgery
after zygomatic implant placed with channel shape osteotomy ,Blunt dissection to buccal space to extract buccal pad of fat which will be mobilized and advanced to cover buccal surface of zygomatic implants and fixed over it with either suturing to palatal mucosa or with bone tacs

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: group AActive comparator 1 intervention

Group B: group BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1-soft tissue thickness 2-Soft tissue recession

For soft tissue recession, a clinical visual exploration was performed, and defects were measured through a periodontal probe from fixed reference point (buccal surface of implant platform). For soft tissue thickness, a clinical method by using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe

Time frame

6 months of healing

Secondary outcomes

Bone gain

CBCT used to determine bone gain in group A

Time frame

6 months of healing

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fayoum University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: