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Active, Not Recruiting

NCT Number: NCT06604676

Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use

The goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one. The main questions it aims to answer are:

* Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow? * What is the difference in time efficiency between conventional and digital protocols? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.

Participants will:

* Receive periodontal surgery to treat gingival recession site * Visit the clinic after 2 weeks for suture removal & filling the survey * The time will be recorded during the surgery

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry ,Tanta University

Tanta, tanta, 02040, Egypt

About this study

50 sites will be included. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for ethical approval. All participants will provide written informed consent after receiving explanations on study objectives and procedures. Primary outcomes will be patient- and operator-centered outcomes. Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS), questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices. Secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure. The treatment phases will include digital analysis of landmarks and design, of the guide and surgical phase (free gingival graft harvesting ). Time will be recorded in minutes. All the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed. The planned duration for the research will be 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • area need soft tissue augmentation around teeth either coronal or apical to recession
  • must have a general health showing no contraindications for oral surgery must be at least 20 years old.
  • patients also had to have good oral hygiene before the treatment

Exclusion criteria

  • signs or symptoms of bruxism or clenching
  • if they were suffering from uncontrolled systemic conditions

Treatment and study plan

guided soft tissue grafting

Procedure

guided soft tissue grafting techniquea special digital guide was fabricated for one intervention non-guided soft tissue grafting technique receive the traditional technique without guide

non-guided soft tissue grafting technique

Procedure

the graft was taken with traditional technique without guide

Primary outcomes

  1. Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)

    Time frame: 6 months

    Primary outcome will be patient- and operator-centered outcome. Patient- and operator-centered outcome will be assessed through visual analogue scale (VAS).

  2. The questionnaires containing self-developed questions about each phase of the treatment

    Time frame: 6 months

    The questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices.

Secondary outcomes

  1. The time-efficiency by assessing workflow duration

    Time frame: 6 months

    Secondary outcome will be time-efficiency by assessing workflow duration

  2. The number of appointments needed to complete the procedure

    Time frame: 6 months

    Secondary outcome will be number of appointments needed to complete the procedure

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided

Acronym: RCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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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