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NCT Number: NCT06620367

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Tanta university

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. flap dehiscence

    Time frame: 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 outcomes

  1. bone gain

    Time frame: 6 months

    bone gain will be assessed using cone beam computed tomography (CBCT)

  2. bone denisty

    Time frame: 6 months

    cone beam computed tomography (CBCT) will be used to asses bone density

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide

Acronym: RCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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