Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow (RCT)

Tanta University

Status: Active, not recruiting

Conditions: Digital Guided Bone Regeneration

Treatments: Procedure: conventional guided bone regeneration; Procedure: digital guided bone regeneration

Study type: Interventional

Funder types: Other

Identifiers

NCT06620367

#R-OMPDR- 6-24-3122

Details and patient eligibility

About

The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:

• Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?
• What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.

Participants will:

• Receive guided bone regeneration around implant
• Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence
• Bone gain and bone density will be assessed after 6 months

Full description

Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide & 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.

Enrollment: 20 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• medium horizontal ridge defect according to clone classification
• must have a general health showing no contraindications for surgery
• must be at least 35 years old
• patients also have adequate soft tissue thickness and width of keratinized gingiva

Exclusion criteria

• no sign of uncontrolled systemic diseases
• non smoker
• not pregnant
• sever ridge deficient
• patients below 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

conventional guided bone regeneration

Active Comparator group

Description:

a medium horizontal ridge defect will receive bone graft and covered with membrane

Treatment:

Procedure: conventional guided bone regeneration

digital guided bone regeneration

Active Comparator group

Description:

digital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane

Treatment:

Procedure: digital guided bone regeneration