Gingival RecessionNCT05470660
Coronally Advanced Flap With Alloderm Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession
A study testing Root coverage using coronally advanced flap combined with micro-needling and coronally advanced flap combined with Alloderm in people with Gingival Recession and Recession, Gingival, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (GT) and keratinized tissue width (KTW) and compare it to Alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Recession, Gingival, Thin-gingiva
- What is being tested?
- Root coverage using coronally advanced flap combined with micro-needling and coronally advanced flap combined with Alloderm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2022to 15 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient consulting in the outpatient clinic.
- Able to tolerate the study procedures.
- Patient ready to perform oral hygiene instructions.
- Compliance with the maintenance program.
- Provide informed consent.
- Accepts the 6 months follow-up period
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- Mature permanent tooth.
- Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- Presence of identifiable Cemento-enamel Junction.
- RT1 facial recession defect of ≥3 mm.
- Clinical indication and/or patient request for recession coverage
Who cannot join
- Medically compromised patients.
- use of any drugs that might lead to gingival enlargement
- Pregnant or nursing women.
- Uncooperative patients.
- Smokers.
- Teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
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- Cairo Recession Type 3 (RT3) recession defects.
- Teeth with active orthodontic treatment.
- Previous periodontal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Coronally Advanced Flap With Acellular Dermal Matrix (Alloderm) Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession: A Pilot Study
This study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (GT) and keratinized tissue width (KTW) and compare it to Alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession type 1 (RT1)
Read the detailed description
Gingival or periodontal diseases were found to occur more likely in patients with a thin gingival biotype. The periodontal phenotype was also found to show stronger correlation with gingival thickness rather than keratinized tissue width and papilla height. Moreover, the thin gingiva was usually found to be associated with thin bony plate with potential for dehiscence and fenestration and hence was thought to be at risk for recession after trauma.
Several techniques have been recommended for the treatment of gingival recession. One of the most predictable outcome is associated with the use of a coronally advanced flap and acellular dermal matrix graft.
Treatment of thin periodontal phenotype through the conjunction of i-PRF and micro-needling may be a first move of the non-surgical approach for improving the gingival thickness. Micro-needling was proved to be generally an effective and safe therapeutic option for numerous dermatologic conditions as clinical improvement of scars, striae, and rhytids with appropriate recovery and limited side effects. The controlled dermal wounding and stimulation of the wound healing cascade through Micro-needling was found to enhance collagen production and thus was responsible for the clinical results obtained.
Therefore, this study will be aiming to compare the effect of micro-needling on the gingival thickness in root coverage procedures. It will also provide an insight of its effect on the patient related factors and the root coverage parameters.
- Conditions
- Gingival Recession, Recession, Gingival, Thin-gingiva
- Being tested
- Root coverage using coronally advanced flap combined with micro-needling, coronally advanced flap combined with Alloderm
- Keywords
- RT1, Recession, micro-needling, micro-needles, Coronally Advanced Flap, Alloderm
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage using coronally advanced flap combined with micro-needlingProcedure or surgery
modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing.
coronally advanced flap combined with AllodermProcedure or surgery
modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it.
| Study group | Role | What they receive |
|---|---|---|
| Root coverage using coronally advanced flap combined with micro-needling | Experimental | modified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing Receives: Procedure: Root coverage using coronally advanced flap combined with micro-needling |
| coronally advanced flap combined with Alloderm | Active comparator | modified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it. Receives: Procedure: coronally advanced flap combined with Alloderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness (GT) in mm
Gingival thickness (GT) will be specified at a mid-buccal location approximately 1 mm apical to the probing depth (PD) level with a #15 endodontic spreader. The reamer will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface and fixed by a drop of cyanoacrylate adhesive; after careful removal of the reamer, penetration depth will be measured with a caliper to the nearest 0.1 mm gingival thickness changes will be calculated after 6 months
Measured: 6 months
Secondary outcomes (5)
Keratinized tissue width (KTW) in mm
Keratinized tissue (KT) will be measured from the most apical point of the gingival margin to the mucogingival junction measurements will be recorded at baseline and after 6 months
Measured: 6 months
Clinical Attachment Level (CAL) in mm
Will be measured from the Cemento-enamel Junction to the bottom of the gingival sulcus at baseline and 6 months
Measured: 6 months
Gingival Recession Depth (RD) in mm
Will be measured from the Cemento-enamel Junction to the most apical extension of the gingival margin.
Measured: 6 months
Gingival Recession Width (RW) in mm
Will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.
Measured: 6 months
Percentage of root coverage
Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
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 posted22 Jul 2022
- Study start2 Jul 2022
- Primary completion10 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ossama Ezzat Moursy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470660
- Sponsor's protocol ID
- PER331
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
PubMed 28796657Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
PubMed 18724847Cortes Ade Q, Martins AG, Nociti FH Jr, Sallum AW, Casati MZ, Sallum EA. Coronally positioned flap with or without acellular dermal matrix graft in the treatment of Class I gingival recessions: a randomized controlled clinical study. J Periodontol. 2004 Aug;75(8):1137-44. doi: 10.1902/jop.2004.75.8.1137.
PubMed 15455743
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coronally Advanced Flap With Acellular Dermal Matrix (Alloderm) Versus Coronally Advanced Flap With Micro-needling on RT1 Gingival Recession: A Pilot Study
- ClinicalTrials.gov ID
- NCT05470660
- Acronym / sponsor ID
- PER331
- Conditions
- Gingival Recession, Recession, Gingival, Thin-gingiva
- Keywords
- RT1, Recession, micro-needling, micro-needles, Coronally Advanced Flap, Alloderm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 22 Jul 2022 (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.
This study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (GT) and keratinized tissue width (KTW) and compare it to Alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession type 1 (RT1)
Detailed description
Gingival or periodontal diseases were found to occur more likely in patients with a thin gingival biotype. The periodontal phenotype was also found to show stronger correlation with gingival thickness rather than keratinized tissue width and papilla height. Moreover, the thin gingiva was usually found to be associated with thin bony plate with potential for dehiscence and fenestration and hence was thought to be at risk for recession after trauma.
Several techniques have been recommended for the treatment of gingival recession. One of the most predictable outcome is associated with the use of a coronally advanced flap and acellular dermal matrix graft.
Treatment of thin periodontal phenotype through the conjunction of i-PRF and micro-needling may be a first move of the non-surgical approach for improving the gingival thickness. Micro-needling was proved to be generally an effective and safe therapeutic option for numerous dermatologic conditions as clinical improvement of scars, striae, and rhytids with appropriate recovery and limited side effects. The controlled dermal wounding and stimulation of the wound healing cascade through Micro-needling was found to enhance collagen production and thus was responsible for the clinical results obtained.
Therefore, this study will be aiming to compare the effect of micro-needling on the gingival thickness in root coverage procedures. It will also provide an insight of its effect on the patient related factors and the root coverage parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root coverage using coronally advanced flap combined with micro-needling | Experimental | Procedure: Root coverage using coronally advanced flap combined with micro-needlingmodified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing |
| coronally advanced flap combined with Alloderm | Active comparator | Procedure: coronally advanced flap combined with Allodermmodified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient consulting in the outpatient clinic.
- Mature permanent tooth.
- Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- Presence of identifiable Cemento-enamel Junction.
- RT1 facial recession defect of ≥3 mm.
Key exclusion criteria (9 listed)
- Medically compromised patients.
- Teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
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 |
|---|---|---|
| Root coverage using coronally advanced flap combined with micro-needlingmodified coronally advanced flap will be performed in sites of recession defects, then micro-needling will be performed after 1 month from the coronally advanced flap procedure to ensure the initial flap healing. | Procedure or surgery | Root coverage using coronally advanced flap combined with micro-needling |
| coronally advanced flap combined with Allodermmodified coronally advanced flap will be performed in sites of recession defects in Association with alloderm to cover the exposed root and 3 mm of connective tissue mesial and distal to it. | Procedure or surgery | coronally advanced flap combined with Alloderm |
Primary outcome
Gingival thickness (GT) in mm
Time frame: 6 months
Gingival thickness (GT) will be specified at a mid-buccal location approximately 1 mm apical to the probing depth (PD) level with a #15 endodontic spreader. The reamer will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface and fixed by a drop of cyanoacrylate adhesive; after careful removal of the reamer, penetration depth will be measured with a caliper to the nearest 0.1 mm gingival thickness changes will be calculated after 6 months
5 secondary outcomes
Keratinized tissue width (KTW) in mm
Time frame: 6 months
Clinical Attachment Level (CAL) in mm
Time frame: 6 months
Gingival Recession Depth (RD) in mm
Time frame: 6 months
Gingival Recession Width (RW) in mm
Time frame: 6 months
Percentage of root coverage
Time frame: 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 24 Jul 2026.
- Background: PubMed 28796657Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
- Background: PubMed 18724847Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
- Background: PubMed 15455743Cortes Ade Q, Martins AG, Nociti FH Jr, Sallum AW, Casati MZ, Sallum EA. Coronally positioned flap with or without acellular dermal matrix graft in the treatment of Class I gingival recessions: a randomized controlled clinical study. J Periodontol. 2004 Aug;75(8):1137-44. doi: 10.1902/jop.2004.75.8.1137.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root coverage using coronally advanced flap combined with micro-needling and coronally advanced flap combined with Alloderm in people with Gingival Recession and Recession, Gingival, 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 11 inclusion and 9 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 24 Jul 2026. 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?
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?
Gingival thickness (GT) in mm (time frame: 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 NCT05470660, which also lists 3 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 24 Jul 2026.