Gingival Recession, LocalizedPhase 4NCT06508476
The Efficacy of Amnion Chorion Allograft in Management of Gingival Recession.
A Phase 4 study testing Amnion Chorion membrane and connective tissue graft in people with Gingival Recession, Localized, run by Minia University at 1 site in Egypt.
Trial summary
the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Amnion Chorion membrane and connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 22 Mar 2025
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Selected patients of both sexes are 25-45 years old.
- Patients are systemically healthy based on the questionnaire dental modification of the Cornell index.
- O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
- Buccal recession defects are classified RT1 according to Cairo's classification (2011).
- Clinical indication and/or patient request for recession coverage.
Who cannot join
- RT2 and RT3 recession defects.
- Pregnant female.
- Smokers.
- Patients with special needs or with any mental problems.
- All patients are using any kind of medication that could interfere with the healing of periodontal tissues. Such as chemotherapy and radiotherapy.
- Teeth with root carious lesions.
- Rotated and extruded teeth.
- Patients underwent any prior periodontal surgery in the relevant region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Amnion Chorion Allograft in Management of Type 1 Gingival Recession. (Randomized Clinical Trial)
the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft.
Read the detailed description
Gingival recession (GR) is characterized by apical migration of soft tissue margin beyond the cemento-enamel junction (CEJ) or the platform of an implant.
Gingival recession is a common daily finding in every practice. As patients are more concerned with a pleasing smile, root exposure is a growing concern . Moreover, discomfort and inability to perform oral hygiene result from exposed root hypersensitivity. It affects the patient's abilities to maintain adequate plaque control which eventually complicates the situation more. It is advisable to augment tissues and increase keratinized tissue (KT) band to reduce discomfort and obtain an aesthetic smile.
multiple treatment modalities are available for treating gingival recession such as Pedicle flaps (coronally advanced flap (CAF), semilunar flap, laterally sliding flap (lSD), and double papilla flap), Free gingival graft (FGG), Subepithelial connective tissue graft (SCTG), Guided tissue regeneration. Modified coronally advanced tunnel, Vestibular incision subperiosteal tunnel access (VISTA), Pinhole technique (PST).
Size and number of recession defects, KT band, interproximal attachment level, depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession.
For single-type recession (localized or isolated), the use of CAF with SCTG is favorable for both root coverage and KT gain. According to the American Academy of Periodontology regeneration workshop "for Miller class 1 and 2 single-tooth recession defects, SCTG procedures provide the best outcome ". Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects. SCTG improves root coverage, KT gain, and clinical attachment levels. Using SCTG helps stabilize CAF, increase root coverage predictability, and increase soft tissue thickness. CAF with SCTG is a predictable technique to increase root coverage, decrease recession depth, and increase KT width and thickness.
However, obtaining an SCTG has some drawbacks such as the need for a second surgical site to harvest graft increases treatment time and patient morbidity. Bleeding and postoperative discomfort are common after graft harvesting. Another issue is a limited amount of tissue is also a concern in multiple defect cases. Patients' willingness to retreat was affected by previous autogenous grafting.
Recently, the use of placental membranes is introduced as a suitable substitute for SCTG. The human placenta is composed of two membranes inner amniotic and outer chorionic membranes. These membranes secrete anti-inflammatory cytokines and growth factors such as platelet-derived growth factor AA (PDGF-AA) and vascular endothelial growth factor (VEGF). These membranes have anti-inflammatory, angiogenic, antifibrotic, and antimicrobial effects. Furthermore, they have low immunogenicity and improve epithelization. They have been widely used in medicine since the 1910s with increasing clinical applications from wound care and ophthalmology, to plastic surgery.
There is a growing interest in using placental allografts as a substitute for conventional membranes in oral surgical procedures. They are used for root coverage as a substitute for SCTG as these membranes contain different types of collagen, proteoglycans, laminin, and bioactive factors which help in binding gingival epithelial cells to the root surface. They act as reservoirs of stem cells which promote cell differentiation, stimulate healing, and help in revascularization.
So in this study, it is proposed to evaluate Amnion Chorion membrane in the management of gingival recession type 1 in comparison to SCTG.
Aim of the study The primary outcome is to evaluate the effectiveness of the Amnion Chorion membrane (ACM) in the management of gingival recession type 1 (RT1).
The secondary outcome is to compare between ACM and subepithelial connective tissue graft in the treatment of recession defect type 1 (RT1).
- Conditions
- Gingival Recession, Localized
- Being tested
- Amnion Chorion membrane, 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.
Amnion Chorion membraneBiological
it is a placental allograft.
connective tissue graftProcedure or surgery
it is an autograft
| Study group | Role | What they receive |
|---|---|---|
| Amnion chorion allograft | Experimental | participants will receive amnion chorion with coronally advanced flap Receives: Biological: Amnion Chorion membrane |
| Connective tissue graft | Active comparator | participants will receive connective tissue graft with coronally advanced flap Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
recession depth
recession depth is measured from CEJ to the gingival margin in millimeters.
Measured: changes in millimeters from base line to follow up after 6 months
Secondary outcomes (4)
Recession Width
it is measured at the widest point from the mesial gingival margin to the distal gingival margin in millimeters
Measured: changes in millimeters from base line to follow up after 6 months
the height of keratinized gingiva
it is measured in millimeters as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction location determined using a visual method.
Measured: changes in millimeters from base line to follow up after 6 months
Probing pocket depth
it is measured as the distance from the gingival margin to base of pocket.
Measured: changes in millimeters from base line to follow up after 6 months
percentage of root coverage
it will be calculated as [pre-operative gingival recession depth - post-operative recession depth]/ [preoperative recession depth] * 100%
Measured: changes in percentile from base line to follow up after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Jan 2025
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Minia 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
- two groups Group 1 contains 16 patients and will be treated by CAF and SCTG. Group 2 also contains 16 patients and will be treated by CAF and ACM (bioxclude, snoasis medical, Denver, Co.USA).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina gerges, Minia University
- Investigators
- Ahmed Khalil, professor, Study chair, Minia UniversityAya Mohammed, Lecturer, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508476
- Sponsor's protocol ID
- 857
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Amine K, El Amrani Y, Chemlali S, Kissa J. Alternatives to connective tissue graft in the treatment of localized gingival recessions: A systematic review. J Stomatol Oral Maxillofac Surg. 2018 Feb;119(1):25-32. doi: 10.1016/j.jormas.2017.09.005. Epub 2017 Sep 9.
PubMed 28893718Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
PubMed 21507033Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
PubMed 18584934Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
PubMed 21859324Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.
PubMed 30277568Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
PubMed 25644302de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PubMed 17309597Gulameabasse S, Gindraux F, Catros S, Fricain JC, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res B Appl Biomater. 2021 Aug;109(8):1216-1229. doi: 10.1002/jbm.b.34783. Epub 2020 Dec 22.
PubMed 33354857Imber JC, Kasaj A. Treatment of Gingival Recession: When and How? Int Dent J. 2021 Jun;71(3):178-187. doi: 10.1111/idj.12617. Epub 2021 Jan 29.
PubMed 34024328Madeley E, Duane B. Coronally advanced flap combined with connective tissue graft; treatment of choice for root coverage following recession? Evid Based Dent. 2017 Mar;18(1):6-7. doi: 10.1038/sj.ebd.6401215.
PubMed 28338039Maity S, Priyadharshini V. Comparison of chorion allograft and subepithelial connective tissue autograft in the treatment of gingival recession- A randomized controlled clinical trial. J Oral Biol Craniofac Res. 2023 Mar-Apr;13(2):104-110. doi: 10.1016/j.jobcr.2022.12.002. Epub 2022 Dec 5.
PubMed 36578557Moraschini V, Barboza Edos S. Use of Platelet-Rich Fibrin Membrane in the Treatment of Gingival Recession: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Mar;87(3):281-90. doi: 10.1902/jop.2015.150420. Epub 2015 Nov 12.
PubMed 26561997Moraschini V, Calasans-Maia MD, Dias AT, de Carvalho Formiga M, Sartoretto SC, Sculean A, Shibli JA. Effectiveness of connective tissue graft substitutes for the treatment of gingival recessions compared with coronally advanced flap: a network meta-analysis. Clin Oral Investig. 2020 Oct;24(10):3395-3406. doi: 10.1007/s00784-020-03547-3. Epub 2020 Aug 26.
PubMed 32851531Mounssif I, Stefanini M, Mazzotti C, Marzadori M, Sangiorgi M, Zucchelli G. Esthetic evaluation and patient-centered outcomes in root-coverage procedures. Periodontol 2000. 2018 Jun;77(1):19-53. doi: 10.1111/prd.12216. Epub 2018 Mar 4.
PubMed 29504166Pini-Prato G. The Miller classification of gingival recession: limits and drawbacks. J Clin Periodontol. 2011 Mar;38(3):243-5. doi: 10.1111/j.1600-051X.2010.01655.x. Epub 2010 Dec 15. No abstract available.
PubMed 21158897
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Amnion Chorion Allograft in Management of Type 1 Gingival Recession. (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06508476
- Acronym / sponsor ID
- 857
- Conditions
- Gingival Recession, Localized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 18 Jul 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 main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft.
Detailed description
Gingival recession (GR) is characterized by apical migration of soft tissue margin beyond the cemento-enamel junction (CEJ) or the platform of an implant.
Gingival recession is a common daily finding in every practice. As patients are more concerned with a pleasing smile, root exposure is a growing concern . Moreover, discomfort and inability to perform oral hygiene result from exposed root hypersensitivity. It affects the patient's abilities to maintain adequate plaque control which eventually complicates the situation more. It is advisable to augment tissues and increase keratinized tissue (KT) band to reduce discomfort and obtain an aesthetic smile.
multiple treatment modalities are available for treating gingival recession such as Pedicle flaps (coronally advanced flap (CAF), semilunar flap, laterally sliding flap (lSD), and double papilla flap), Free gingival graft (FGG), Subepithelial connective tissue graft (SCTG), Guided tissue regeneration. Modified coronally advanced tunnel, Vestibular incision subperiosteal tunnel access (VISTA), Pinhole technique (PST).
Size and number of recession defects, KT band, interproximal attachment level, depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession.
For single-type recession (localized or isolated), the use of CAF with SCTG is favorable for both root coverage and KT gain. According to the American Academy of Periodontology regeneration workshop "for Miller class 1 and 2 single-tooth recession defects, SCTG procedures provide the best outcome ". Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects. SCTG improves root coverage, KT gain, and clinical attachment levels. Using SCTG helps stabilize CAF, increase root coverage predictability, and increase soft tissue thickness. CAF with SCTG is a predictable technique to increase root coverage, decrease recession depth, and increase KT width and thickness.
However, obtaining an SCTG has some drawbacks such as the need for a second surgical site to harvest graft increases treatment time and patient morbidity. Bleeding and postoperative discomfort are common after graft harvesting. Another issue is a limited amount of tissue is also a concern in multiple defect cases. Patients' willingness to retreat was affected by previous autogenous grafting.
Recently, the use of placental membranes is introduced as a suitable substitute for SCTG. The human placenta is composed of two membranes inner amniotic and outer chorionic membranes. These membranes secrete anti-inflammatory cytokines and growth factors such as platelet-derived growth factor AA (PDGF-AA) and vascular endothelial growth factor (VEGF). These membranes have anti-inflammatory, angiogenic, antifibrotic, and antimicrobial effects. Furthermore, they have low immunogenicity and improve epithelization. They have been widely used in medicine since the 1910s with increasing clinical applications from wound care and ophthalmology, to plastic surgery.
There is a growing interest in using placental allografts as a substitute for conventional membranes in oral surgical procedures. They are used for root coverage as a substitute for SCTG as these membranes contain different types of collagen, proteoglycans, laminin, and bioactive factors which help in binding gingival epithelial cells to the root surface. They act as reservoirs of stem cells which promote cell differentiation, stimulate healing, and help in revascularization.
So in this study, it is proposed to evaluate Amnion Chorion membrane in the management of gingival recession type 1 in comparison to SCTG.
Aim of the study The primary outcome is to evaluate the effectiveness of the Amnion Chorion membrane (ACM) in the management of gingival recession type 1 (RT1).
The secondary outcome is to compare between ACM and subepithelial connective tissue graft in the treatment of recession defect type 1 (RT1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups Group 1 contains 16 patients and will be treated by CAF and SCTG. Group 2 also contains 16 patients and will be treated by CAF and ACM (bioxclude, snoasis medical, Denver, Co.USA).
| Arm | Type | Receives |
|---|---|---|
| Amnion chorion allograft | Experimental | Biological: Amnion Chorion membraneparticipants will receive amnion chorion with coronally advanced flap |
| Connective tissue graft | Active comparator | Procedure: connective tissue graftparticipants will receive connective tissue graft with coronally advanced flap |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Selected patients of both sexes are 25-45 years old.
- Patients are systemically healthy based on the questionnaire dental modification of the Cornell index.
- O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
- Buccal recession defects are classified RT1 according to Cairo's classification (2011).
- Clinical indication and/or patient request for recession coverage.
Key exclusion criteria (8 listed)
- RT2 and RT3 recession defects.
- Pregnant female.
- Smokers.
- Patients with special needs or with any mental problems.
- All patients are using any kind of medication that could interfere with the healing of periodontal tissues. Such as chemotherapy and radiotherapy.
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 |
|---|---|---|
| Amnion Chorion membraneit is a placental allograft. | Biological | Amnion chorion allograft |
| connective tissue graftit is an autograft | Procedure or surgery | Connective tissue graft |
Primary outcome
recession depth
Time frame: changes in millimeters from base line to follow up after 6 months
recession depth is measured from CEJ to the gingival margin in millimeters.
4 secondary outcomes
Recession Width
Time frame: changes in millimeters from base line to follow up after 6 months
the height of keratinized gingiva
Time frame: changes in millimeters from base line to follow up after 6 months
Probing pocket depth
Time frame: changes in millimeters from base line to follow up after 6 months
percentage of root coverage
Time frame: changes in percentile from base line to follow up after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 28893718Amine K, El Amrani Y, Chemlali S, Kissa J. Alternatives to connective tissue graft in the treatment of localized gingival recessions: A systematic review. J Stomatol Oral Maxillofac Surg. 2018 Feb;119(1):25-32. doi: 10.1016/j.jormas.2017.09.005. Epub 2017 Sep 9.
- Background: PubMed 21507033Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
- Background: PubMed 18584934Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
- Background: PubMed 21859324Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
- Background: PubMed 30277568Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.
- Background: PubMed 25644302Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
- Background: PubMed 17309597de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
- Background: PubMed 33354857Gulameabasse S, Gindraux F, Catros S, Fricain JC, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res B Appl Biomater. 2021 Aug;109(8):1216-1229. doi: 10.1002/jbm.b.34783. Epub 2020 Dec 22.
- Background: PubMed 34024328Imber JC, Kasaj A. Treatment of Gingival Recession: When and How? Int Dent J. 2021 Jun;71(3):178-187. doi: 10.1111/idj.12617. Epub 2021 Jan 29.
- Background: PubMed 28338039Madeley E, Duane B. Coronally advanced flap combined with connective tissue graft; treatment of choice for root coverage following recession? Evid Based Dent. 2017 Mar;18(1):6-7. doi: 10.1038/sj.ebd.6401215.
- Background: PubMed 36578557Maity S, Priyadharshini V. Comparison of chorion allograft and subepithelial connective tissue autograft in the treatment of gingival recession- A randomized controlled clinical trial. J Oral Biol Craniofac Res. 2023 Mar-Apr;13(2):104-110. doi: 10.1016/j.jobcr.2022.12.002. Epub 2022 Dec 5.
- Background: PubMed 26561997Moraschini V, Barboza Edos S. Use of Platelet-Rich Fibrin Membrane in the Treatment of Gingival Recession: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Mar;87(3):281-90. doi: 10.1902/jop.2015.150420. Epub 2015 Nov 12.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Ahmed Khalil, professor study chair
Minia University
Aya Mohammed, Lecturer study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amnion Chorion membrane and connective tissue graft in people with Gingival Recession, Localized, run by Minia 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 8 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: finished, as of the sponsor's last update on 29 May 2025. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
recession depth (time frame: changes in millimeters from base line to follow up after 6 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 NCT06508476, which also lists 17 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 29 May 2025.