Gingival RecessionsRCTNCT06603467
Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites
A study testing non-guided de-epithelialized free gingival graft harvested and guided de-epithelialized free gingival graft harvested in people with Gingival Recessions, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the healing pattern in the palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites. . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gingival Recessions
- What is being tested?
- non-guided de-epithelialized free gingival graft harvested and guided de-epithelialized free gingival graft harvested
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 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
- Gingival recession sited classifies as Cairo type I
- 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 i
- patients suffering from uncontrolled systemic conditions
- smoker
- pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites: a Randomized Clinical Trial
The goal of this clinical trial is to compare the healing pattern in the palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.
. The main questions it aims to answer are:
Read more
- Does the harvesting technique will affect the healing pattern \&the recipient site coverage in the treatment of gingival recession?
Participants will:
- Receive in the recession sites, in group 1 deepithelialized free gingival graft harvested without guide \& group 2: will be covered with graft harvested with guide
- Visit the clinic twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed
- The recession coverage will be assessed at 3\& 6 months after surgery
Read the detailed description
Background: Over the last few years, deepithelialized free gingival graft has become a gold standard treatment modality for increasing the width of keratinized gingiva, root coverage, alveolar ridge deficiencies management of peri-implant tissue abnormalities, and papillary loss. The procedure of harvesting the graft from the palate is often associated with the noteworthy challenge of procurement of the largest volume of tissue possible while minimizing associated trauma to anatomical structure, also special designs of the graft may be required. To meet these requirements and overcome the challenges, an innovative digitally designed guide for harvesting the graft is designed to allow ideally designed graft with minimal trauma to the tissue.
Aim: To compare the healing pattern in palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.
Methodology: Twenty recession sites with RT1 Cairo classification will be recruited for this study. Sites were randomly divided into 2 treatment groups as follows: group 1 :10 sites will be covered with deepithelialized free gingival graft harvested without guide \& group 2 :10 sites will be covered with CTG harvested with guide. Sites in both groups will be covered with laterally or coronally positioned flap. Twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed using the Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10. Regarding soft tissue coverage, Gingival recession depth (GRD) \& Gingival recession width (GRW) will be measured at baseline, 3 and 6 months after surgery. Also, each group will be subjected to intraoral scanning at baseline, 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software.
Statistical analysis will be done using IBM SPSS Statistics for Windows, version 23 (IBM Corp., Armonk, NY, USA). Intergroup analysis was done using Mann-Whitney test and intra-group analysis will be done using Kruskal-Wallis test for all the study parameters. Statistical significance will set at a p-value of less than 0.05.
- Conditions
- Gingival Recessions
- Being tested
- non-guided de-epithelialized free gingival graft harvested, guided de-epithelialized free gingival graft harvested
- Keywords
- gingival recessions
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-guided de-epithelialized free gingival graft harvestedProcedure or surgery
gingival recession will be covered with de-epithelialized free gingival graft harvested without guide
guided de-epithelialized free gingival graft harvestedProcedure or surgery
gingival recession will be covered with de-epithelialized free gingival graft harvested with digital guide
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | gingival recession will be covered with de-epithelialized free gingival graft harvested without guide Receives: Procedure: non-guided de-epithelialized free gingival graft harvested |
| group 2 | Active comparator | gingival recession will be covered with de-epithelialized free gingival graft harvested with guide Receives: Procedure: guided de-epithelialized free gingival graft harvested |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Wound Healing Score (EHS) EHS
Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10
Measured: 6 month
Secondary outcomes (3)
Recession depth
Regarding soft tissue coverage, Gingival recession depth (GRD) from cementoenamel junction to Free gingival margin will be measured at baseline, 3 and 6 months after surgery.
Measured: 6 months
gingival thickness
leach group will be subjected to intraoral scanning at baseline, 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software
Measured: 6 months
recession width
measured at cementoenamel junction from mesial to distal line angel at baseline , 3 months \& 6 months
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 RecessionsStudies 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
- 20 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, lecturer in periodontology, Principal investigator, Faculty of Dentistry, Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603467
- Sponsor's protocol ID
- #R-OMPDR-2-24-3097
- Acronym
- RCT
- Status last verified
- Sep 2024
- First submitted
- 16 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
- Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06603467
- Acronym / sponsor ID
- RCT / #R-OMPDR-2-24-3097
- Conditions
- Gingival Recessions
- Keywords
- gingival recessions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 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 compare the healing pattern in the palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.
. The main questions it aims to answer are:
- Does the harvesting technique will affect the healing pattern \&the recipient site coverage in the treatment of gingival recession?
Participants will:
- Receive in the recession sites, in group 1 deepithelialized free gingival graft harvested without guide \& group 2: will be covered with graft harvested with guide
- Visit the clinic twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed
- The recession coverage will be assessed at 3\& 6 months after surgery
Detailed description
Background: Over the last few years, deepithelialized free gingival graft has become a gold standard treatment modality for increasing the width of keratinized gingiva, root coverage, alveolar ridge deficiencies management of peri-implant tissue abnormalities, and papillary loss. The procedure of harvesting the graft from the palate is often associated with the noteworthy challenge of procurement of the largest volume of tissue possible while minimizing associated trauma to anatomical structure, also special designs of the graft may be required. To meet these requirements and overcome the challenges, an innovative digitally designed guide for harvesting the graft is designed to allow ideally designed graft with minimal trauma to the tissue.
Aim: To compare the healing pattern in palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.
Methodology: Twenty recession sites with RT1 Cairo classification will be recruited for this study. Sites were randomly divided into 2 treatment groups as follows: group 1 :10 sites will be covered with deepithelialized free gingival graft harvested without guide \& group 2 :10 sites will be covered with CTG harvested with guide. Sites in both groups will be covered with laterally or coronally positioned flap. Twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed using the Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10. Regarding soft tissue coverage, Gingival recession depth (GRD) \& Gingival recession width (GRW) will be measured at baseline, 3 and 6 months after surgery. Also, each group will be subjected to intraoral scanning at baseline, 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software.
Statistical analysis will be done using IBM SPSS Statistics for Windows, version 23 (IBM Corp., Armonk, NY, USA). Intergroup analysis was done using Mann-Whitney test and intra-group analysis will be done using Kruskal-Wallis test for all the study parameters. Statistical significance will set at a p-value of less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: non-guided de-epithelialized free gingival graft harvestedgingival recession will be covered with de-epithelialized free gingival graft harvested without guide |
| group 2 | Active comparator | Procedure: guided de-epithelialized free gingival graft harvestedgingival recession will be covered with de-epithelialized free gingival graft harvested with guide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gingival recession sited classifies as Cairo type I
- 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 (4 listed)
- signs or symptoms of bruxism or clenching i
- patients suffering from uncontrolled systemic conditions
- smoker
- pregnant or lactating
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 |
|---|---|---|
| non-guided de-epithelialized free gingival graft harvestedgingival recession will be covered with de-epithelialized free gingival graft harvested without guide | Procedure or surgery | group 1 |
| guided de-epithelialized free gingival graft harvestedgingival recession will be covered with de-epithelialized free gingival graft harvested with digital guide | Procedure or surgery | group 2 |
Primary outcome
Early Wound Healing Score (EHS) EHS
Time frame: 6 month
Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10
3 secondary outcomes
Recession depth
Time frame: 6 months
gingival thickness
Time frame: 6 months
recession width
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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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, lecturer in periodontology 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 non-guided de-epithelialized free gingival graft harvested and guided de-epithelialized free gingival graft harvested in people with Gingival Recessions, 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 4 inclusion and 4 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?
Early Wound Healing Score (EHS) EHS (time frame: 6 month). 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.