Gingival RecessionNCT06146855
Amnion Membrane Versus DFGG Using the Tunneling Technique in Management of Gingival Recession Defects.
A study testing Tunneling procedure with Amnion Membrane and Tunneling procedure with De-epithelialized Free Gingival Graft in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunneling procedure with Amnion Membrane and Tunneling procedure with De-epithelialized Free Gingival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2024to 1 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Periodontally and systemically healthy.
- Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth.
- Full-mouth plaque and bleeding score of <15% and no probing depths >3 mm.
- Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites.
Who cannot join
- RT3 recession defects.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Presence of caries lesions or restorations in the cervical area.
- Intake of medications which impede periodontal tissue health and healing.
- Medical contraindications for periodontal surgical procedures.
- Uncooperative patients not willing to complete the follow up period.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine
Cairo, 12114
Mohamed Mashaly, Bsc, 00201226442241, mohamed.mashaly@dentistry.cu.edu.eg
About this study
Official title: Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.
Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000).
Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage.
Read more
The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini \& Pini Prato 2012).
The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.
- Conditions
- Gingival Recession
- Being tested
- Tunneling procedure with Amnion Membrane, Tunneling procedure with De-epithelialized Free Gingival Graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneling procedure with Amnion MembraneProcedure or surgery
Root Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute
Tunneling procedure with De-epithelialized Free Gingival GraftProcedure or surgery
Root Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft
| Study group | Role | What they receive |
|---|---|---|
| Tunneling with amnion membrane | Experimental | Not described Receives: Procedure: Tunneling procedure with Amnion Membrane |
| Tunneling with De-epithelialized Free Gingival Graft | Active comparator | Not described Receives: Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth
Measured from the CEJ to the most apical extension of the gingival margin.
Measured: 3-6 month
Secondary outcomes (8)
Recession width
Measured horizontally between the borders of the recession.
Measured: 3-6 month
Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Measured: 6 months
Root coverage esthetic score
Based on Cairo et al., (2009) the root coverage esthetic score (RES) system evaluated five variables 6 months following surgery: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).
Measured: 6 months
Gingival Thickness
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. After careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm (Paolantonio et al., 2002; da Silva et al., 2004; Joly et al., 2007).
Measured: 3-6 months
Keratinized tissue width
Measured as the distance between the gingival margin and the mucogingival junction (MGJ).
Measured: 3-6 months
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first week postoperatively.
Measured: 1 week
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7- point answer scale. (Kiyak et al., 1984)
Measured: 1 week
Surgical time
Total time of the surgical procedure measured using a stopwatch.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start5 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mashaly, Cairo University
- Investigators
- Mohamed Mashaly, MSc, Principal investigator, Assistant lecturer of Periodontology, Cairo UniversityNoha Ghallab, Phd, Study chair, Professor of Oral Medicine and Periodontology, Cairo UniversityWeam El Battawy, Phd, Study director, Assistant Professor of Oral Medicine and Periodontology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146855
- Sponsor's protocol ID
- AMvsDFGG
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.
PubMed 33751615Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12.
PubMed 24364174
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06146855
- Acronym / sponsor ID
- AMvsDFGG
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Nov 2023 (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.
Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000).
Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage.
The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini \& Pini Prato 2012).
The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunneling with amnion membrane | Experimental | Procedure: Tunneling procedure with Amnion Membrane |
| Tunneling with De-epithelialized Free Gingival Graft | Active comparator | Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years.
- Periodontally and systemically healthy.
- Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth.
- Full-mouth plaque and bleeding score of <15% and no probing depths >3 mm.
- Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites.
Key exclusion criteria (7 listed)
- RT3 recession defects.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Presence of caries lesions or restorations in the cervical area.
- Intake of medications which impede periodontal tissue health and healing.
- Medical contraindications for periodontal surgical procedures.
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 |
|---|---|---|
| Tunneling procedure with Amnion MembraneRoot Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute | Procedure or surgery | Tunneling with amnion membrane |
| Tunneling procedure with De-epithelialized Free Gingival GraftRoot Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft | Procedure or surgery | Tunneling with De-epithelialized Free Gingival Graft |
Primary outcome
Recession depth
Time frame: 3-6 month
Measured from the CEJ to the most apical extension of the gingival margin.
8 secondary outcomes
Recession width
Time frame: 3-6 month
Percentage of root coverage
Time frame: 6 months
Root coverage esthetic score
Time frame: 6 months
Gingival Thickness
Time frame: 3-6 months
Keratinized tissue width
Time frame: 3-6 months
Post-Operative Pain
Time frame: 1 week
Post-Surgical Patient Satisfaction
Time frame: 1 week
Surgical time
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 33751615Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.
- Background: PubMed 24364174Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12.
- Individual participant dataSharing planned: Yes
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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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.
Mohamed Mashaly, MSc principal investigator
Assistant lecturer of Periodontology, Cairo University
Noha Ghallab, Phd study chair
Professor of Oral Medicine and Periodontology, Cairo University
Weam El Battawy, Phd study director
Assistant Professor of Oral Medicine and Periodontology, Cairo 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 Tunneling procedure with Amnion Membrane and Tunneling procedure with De-epithelialized Free Gingival Graft in people with Gingival Recession, run by Cairo 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 5 inclusion and 7 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 13 Feb 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?
Contact Mohamed Mashaly, MSc (00201226442241, mohamed.mashaly@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (time frame: 3-6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146855, which also lists 2 linked publications.
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 13 Feb 2024.