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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Egypt1 site
  • Faculty of Dentistry,Tanta university

    Tanta, Tanta, 020240

Other trials in Egypt

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.

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 groups in NCT06603467
Study groupRoleWhat they receive
group 1Active comparatorgingival recession will be covered with de-epithelialized free gingival graft harvested without guide
Receives: Procedure: non-guided de-epithelialized free gingival graft harvested
group 2Active comparatorgingival 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted19 Sep 2024
  2. Study start15 Apr 2024
  3. Primary completion15 Sep 2024 (estimated)
  4. Study completion15 Oct 2024 (estimated)

Resources

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)
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

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.

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