Gingival RecessionRCTNCT06604676
Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use
A study testing guided soft tissue grafting and non-guided soft tissue grafting technique in people with Gingival Recession, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- guided soft tissue grafting and non-guided soft tissue grafting technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- signs or symptoms of bruxism or clenching
- if they were suffering from uncontrolled systemic conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided
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.
Read more
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
Read the detailed description
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.
- Conditions
- Gingival Recession
- Being tested
- guided soft tissue grafting, non-guided soft tissue grafting technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided soft tissue graftingProcedure or surgery
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 techniqueProcedure or surgery
the graft was taken with traditional technique without guide
| Study group | Role | What they receive |
|---|---|---|
| guided soft tissue grafting technique | Active comparator | aguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded Receives: Procedure: guided soft tissue grafting |
| non-guided soft tissue grafting technique | Active comparator | the graft was taken with the scalpel without guide Receives: Procedure: non-guided soft tissue grafting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS)
Primary outcome will be patient- and operator-centered outcome. Patient- and operator-centered outcome will be assessed through visual analogue scale (VAS).
Measured: 6 months
The questionnaires containing self-developed questions about each phase of the treatment
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.
Measured: 6 months
Secondary outcomes (2)
The time-efficiency by assessing workflow duration
Secondary outcome will be time-efficiency by assessing workflow duration
Measured: 6 months
The number of appointments needed to complete the procedure
Secondary outcome will be number of appointments needed to complete the procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Apr 2024
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safinaz saleh mohamed saeed, Tanta University
- Investigators
- bassem nabil elfahl, assistant professor, Principal investigator, faculty of dentistry,tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604676
- Sponsor's protocol ID
- #R-OMPDR-2-24-3096
- Acronym
- RCT
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Operator Centered Outcomes in Harvesting Technique of Soft Tissue Graft: Guided Versus Non-Guided
- ClinicalTrials.gov ID
- NCT06604676
- Acronym / sponsor ID
- RCT / #R-OMPDR-2-24-3096
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided soft tissue grafting technique | Active comparator | Procedure: guided soft tissue graftingaguide was fabricated for harvesting the graft and patient and operater centered outcomes is recorded |
| non-guided soft tissue grafting technique | Active comparator | Procedure: non-guided soft tissue grafting techniquethe graft was taken with the scalpel without guide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- signs or symptoms of bruxism or clenching
- if they were suffering from uncontrolled systemic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided soft tissue graftingguided soft tissue grafting techniquea special digital guide was fabricated for one intervention non-guided soft tissue grafting technique receive the traditional technique without guide | Procedure or surgery | guided soft tissue grafting technique |
| non-guided soft tissue grafting techniquethe graft was taken with traditional technique without guide | Procedure or surgery | non-guided soft tissue grafting technique |
Primary outcome
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).
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.
2 secondary outcomes
The time-efficiency by assessing workflow duration
Time frame: 6 months
The number of appointments needed to complete the procedure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
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Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bassem nabil elfahl, assistant professor principal investigator
faculty of dentistry,tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided soft tissue grafting and non-guided soft tissue grafting technique in people with Gingival Recession, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.