RT2 Gingival RecessionPhase 4NCT04104087
Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession
A Phase 4 study testing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. in people with RT2 Gingival Recession, run by Cairo University.
Trial summary
Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures. According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RT2 Gingival Recession
- What is being tested?
- tunneling technique with sub epithelial connective tissue graft or deepithelialized 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
- No sites listed yet
- Study dates
- 10 Oct 2019to 10 Apr 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site
Who cannot join
- Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
- Overlapping teeth or teeth with abnormal alignment in the dental arch.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.
Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures.
According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.
Read the detailed description
Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects.
Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects.
However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course.
To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue
- Conditions
- RT2 Gingival Recession
- Being tested
- tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
- Keywords
- tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue 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 technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.Procedure or surgery
Also called root coverage
enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
| Study group | Role | What they receive |
|---|---|---|
| deepithelializ free gingival graft | Experimental | performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession Receives: Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. |
| subepithelial connective tissue graft | Active comparator | performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession Receives: Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distance between the contact point and the top of the papilla
measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Oct 2019 (estimated)
- Primary completion10 Jul 2020 (estimated)
- Study completion10 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RT2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it is randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elshourbagy, Cairo University
- Investigators
- Manal Hosny, phd, Study chair, Cairo UniversityHani ElNahass, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104087
- Sponsor's protocol ID
- perio 331
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will check with my study chair
Publications
Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.
PubMed 19968743
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04104087
- Acronym / sponsor ID
- perio 331
- Conditions
- RT2 Gingival Recession
- Keywords
- tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue graft,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (estimated)
- Primary completion
- 10 Jul 2020 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures.
According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.
Detailed description
Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects.
Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects.
However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course.
To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- it is randomized control trial
| Arm | Type | Receives |
|---|---|---|
| deepithelializ free gingival graft | Experimental | Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession |
| subepithelial connective tissue graft | Active comparator | Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site
Key exclusion criteria (2 listed)
- Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
- Overlapping teeth or teeth with abnormal alignment in the dental arch.
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 technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.Also: root coverageenhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. | Procedure or surgery | deepithelializ free gingival graft, subepithelial connective tissue graft |
Primary outcome
the distance between the contact point and the top of the papilla
Time frame: 9 months
measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Results publication: PubMed 19968743Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.
- Individual participant dataSharing planned: Undecided. I will check with my study chair
Related trials for RT2 Gingival Recession
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RecruitingPhase 2/3
Evaluation of the Modified VISTA Technique Using ALB-PRF vs CTG in the Treatment of Multiple Miller Class III Recessions
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Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery
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Clinical Evaluation Comparing Tunneled Coronally Advanced Flap and Modified Coronally Advanced Tunnel With Connective Tissue Graft for Managing Single Gum Recession
Single Recession Defects (RT2)
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Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites
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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.
Manal Hosny, phd study chair
Cairo University
Hani ElNahass, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. in people with RT2 Gingival Recession, run by Cairo University.
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 1 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sarah Elshourbagy, MSC (01288624000, sara_elshourbagy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the distance between the contact point and the top of the papilla (time frame: 9 months). 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 NCT04104087, which also lists 1 linked publication.
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 26 Sep 2019.