Digital Guided Bone Regeneration
Conditions
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 & 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.
Interventions
PROCEDUREconventional guided bone regeneration
10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane stabilized by tacks
PROCEDUREdigital guided bone regeneration
10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) placed by digital designed guide covered with bilayer collagen membrane stabilized by tacks
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| flap dehiscence | 14 days | the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone gain | 6 months | bone gain will be assessed using cone beam computed tomography (CBCT) |
| bone denisty | 6 months | cone beam computed tomography (CBCT) will be used to asses bone density |
Countries
Egypt
Outcome results
None listed