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

NCT06620367 | Active Not Recruiting DMC

• 1 other identifier: #R-OMPDR- 6-24-3122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Digital Guided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• flap dehiscence

  the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins

  14 days

Secondary Outcomes (2)

• bone gain

  6 months

• bone denisty

  6 months

Study Arms (2)

conventional guided bone regeneration

ACTIVE COMPARATOR

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

Procedure: conventional guided bone regeneration

digital guided bone regeneration

ACTIVE COMPARATOR

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

Procedure: digital guided bone regeneration

Interventions

conventional guided bone regeneration PROCEDURE

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

conventional guided bone regeneration

digital guided bone regeneration PROCEDURE

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

digital guided bone regeneration

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry Tanta university

Tanta, Egypt

Location

Study Officials

• Bassem nabil elfahl, assistant professor

  faculty of dentistry Tanta university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of periodontology

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: April 20, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 20, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)