Clinical trial NCT06620367: Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow
Official title: Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Digital Guided Bone Regeneration
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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 \&amp; 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.

Eligibility criteria: 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

Primary outcomes:
measure: flap dehiscence
timeFrame: 14 days
Secondary outcomes:
measure: bone gain
timeFrame: 6 months
measure: bone denisty
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: faculty of dentistry Tanta university
Study officials:
affiliation: faculty of dentistry Tanta university
name: Bassem nabil elfahl, assistant professor
role: PRINCIPAL_INVESTIGATOR
References: