Gingival RecessionIPPFNCT03701191
Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession
A study testing Inverted periosteal pedicle flap in people with Gingival Recession, run by Marwa El Sayed Abbas Ahmed at 1 site in Egypt.
Trial summary
Perioteum in the recession defect site will be used as an autogenous graft after raising a flap and the results will be compared with another group which will be treated by the gold standard ( coronally advanced flap with subepithelial connective tissue graft). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Inverted periosteal pedicle flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2020to 28 Aug 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: Male and Female
- Age: >20 years
- Have RT1 and RT2 gingival recession
Who cannot join
- Medically compromised
- History of certain medications
- Pregnant females
- Periapical involvement in selected teeth
- History of periodontal surgery involving experimental teeth
- If the problem was due to orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university, Faclty of dentistry
Cairo
Ahmed Re Abd El Raman, Ass. Prof., 00201006608568, dr.a.reda@gmail.com
Mona Sa Darhous, Professor, 00201223155955, mona.darhous@dentistry.cu.edu.eg
About this study
Official title: Assessment of Postoperative Discomfort Following Inverted Periosteal Pedicle Flap Versus Coronally Advanced Flap With Subepithelial Connective Tissue Graft in Treatment of Gingival Recession Types 1 and 2. A Randomized Clinical Trial.
Perioteum in the recession defect site will be used as an autogenous graft after raising a flap and the results will be compared with another group which will be treated by the gold standard ( coronally advanced flap with subepithelial connective tissue graft).
Read the detailed description
Eighteen participants will be recruited.
Included participants will be:
- Gender: Male and Female
- Age: >20 years
- Have RT1 and RT2 gingival recession
Exclusion criteria:
- Medically compromised
- History of certain medications
- Pregnant females
- Periapical involvement in selected teeth
- History of periodontal surgery involving experimental teeth
- If the problem was due to orthodontic treatment
- Interventions: Participants will be divided into two groups, group A (test group) and group B ( control group).
Pre-surgical phase (including supragingival scaling and root planning) will be carried out to both groups, followed by oral hygiene instructions.
Then, Participants will be explained about each procedure. 7
For group A (test group):
Inverted periosteal pedicle flap will be carried out as follows according to Shetty 2014:
Patients will be explained about the procedure. Non-surgical phase will include supragingival scaling and root planning, followed by oral hygiene instructions.
The surgical procedure will be carried out three weeks after non-surgical phase as follows:
- Horizontal incisions will be made perpendicular to the adjacent papillae at the level of the cement-enamel junction (CEJ) preserving the gingival margin of the affected teeth.
- Sulcular incisions on the buccal/facial aspect of the involved teeth.
- Vertical incisions extending beyond the mucogingival junction will be made at the line angles of the distal most and the mesial most teeth.
- A partial thickness flap will then be elevated till an adequate amount of periosteum is exposed.
- A horizontal incision will then be given at the apical extent of the periosteum where it is still attached to the bone.
- The periosteum will then be separated from the underlying bone and reflected coronally to an extent where it is still attached to the bone.
- The reflected periosteum will then be inverted such that the cambium layer covers the denuded root.
- Once the periosteum is in place, it is sutured and secured.
- The reflected partial thickness flap will be coronally advanced such that it covers the periosteum and will be sutured using a sling suture.
- The vertical incision will be sutured using an interrupted suture. 8
For group B (control group):
Coronally advanced flap with subepithelial connective tissue graft will be carried out; an envelope flap design will be used according to Zucchelli \& De Sanctis 2000 as follows:
- An intrasulcular incision will be performed involving at least one tooth mesial and at least one tooth distal to the teeth with gingival recessions.
- Oblique incisions will be traced at the interdental soft tissue level to achieve a coronal rotation of the surgical papilla.
- The flap will be then raised up to the mucogingival junction (MGJ) with a periosteal elevator and mobilized with a sharp horizontal periosteal incision beyond the MGJ.
- Exposed root surfaces will be carefully treated with gentle root planing.
- The anatomic interdental papillae will be carefully de-epithelialized.
- The split-full-split thickness flap will be then passively positioned above the CEJ of the involved teeth and interrupted or sling sutures were positioned to achieve optimal buccal flap adaptation.
- The connective tissue graft will be harvested from the palate using the trap door technique (Langer \& Langer 1985), adapted to cover each exposed root about 1 mm beyond the CEJ, and stabilized with resorbable sutures.
- The flap will be then coronally sutured using sling or interrupted sutures.
Post-surgical protocol (Pini-Prato et al.,2010 and Cairo et al., 2016) :
Participants for both groups will be instructed to:
- Intermittently apply an ice bag for the first 4 hours.
- Take ibuprofen 600 mg at the end of the surgical procedure and will be instructed to take another tablet 6 h later and additional doses if needed.
- Avoid any mechanical trauma and tooth-brushing for 3 weeks in the surgical area.
- Smokers will be reminded to quit smoking during the trial time (6 months).
- Chlorexidine rinses will be prescribed twice daily for 1 min. seven days after the surgery.
- Sutures will be removed and prophylaxis will be performed. 9
- About 3 weeks after surgery, patients will be instructed to resume mechanical tooth-cleaning.
Follow up strategy:
Patients will be recalled after 3and 6 months after surgery.
- Conditions
- Gingival Recession
- Being tested
- Inverted periosteal pedicle flap
- Keywords
- gingival recession, periosteum, autogenous 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.
Inverted periosteal pedicle flapProcedure or surgery
The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A
| Study group | Role | What they receive |
|---|---|---|
| Grpup A (Test group) | Experimental | Inverted periosteal pedicle flap will be carried out Receives: Procedure: Inverted periosteal pedicle flap |
| Group B (Control group) | Active comparator | Coronally advanced flap with subepithelial connective tissue graft Receives: Procedure: Inverted periosteal pedicle flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative discomfort
Numerical using Visual analogue scale (VAS) Questionnaire
Measured: 3 weeks
Secondary outcomes (4)
Amount of root coverage
continuous (mm)
Measured: 3 months and 6 months
Probing depth
continuous (mm)
Measured: 3 months and 6 months
esthetics
numerical using Root coverage esthetic score (RES)
Measured: 6 months
patient's satisfaction
categorical via assessment of patient-related criteria using a 3-point rating scale
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 posted9 Oct 2018
- Study start25 Jan 2020 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- Model description
- Included participants will be: 1. Gender: Male and Female 2. Age: \>20 years 3. Have RT1 and RT2 gingival recession Exclusion criteria: 1. Medically compromised 2. History of certain medications 3. Pregnant females 4. Periapical involvement in selected teeth 5. History of periodontal surgery involving experimental teeth 6. If the problem was due to orthodontic treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa El Sayed Abbas Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Marwa El Sayed Abbas Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701191
- Sponsor's protocol ID
- perio 2:5:1
- Acronym
- IPPF
- Status last verified
- Jan 2020
- First submitted
- 7 Oct 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publishing in an international journal
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Discomfort Following Inverted Periosteal Pedicle Flap Versus Coronally Advanced Flap With Subepithelial Connective Tissue Graft in Treatment of Gingival Recession Types 1 and 2. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03701191
- Acronym / sponsor ID
- IPPF / perio 2:5:1
- Conditions
- Gingival Recession
- Keywords
- gingival recession, periosteum, autogenous graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Marwa El Sayed Abbas AhmedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 25 Jan 2020 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Aug 2020 (estimated)
- First posted
- 9 Oct 2018 (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.
Perioteum in the recession defect site will be used as an autogenous graft after raising a flap and the results will be compared with another group which will be treated by the gold standard ( coronally advanced flap with subepithelial connective tissue graft).
Detailed description
Eighteen participants will be recruited.
Included participants will be:
- Gender: Male and Female
- Age: >20 years
- Have RT1 and RT2 gingival recession
Exclusion criteria:
- Medically compromised
- History of certain medications
- Pregnant females
- Periapical involvement in selected teeth
- History of periodontal surgery involving experimental teeth
- If the problem was due to orthodontic treatment
- Interventions: Participants will be divided into two groups, group A (test group) and group B ( control group).
Pre-surgical phase (including supragingival scaling and root planning) will be carried out to both groups, followed by oral hygiene instructions.
Then, Participants will be explained about each procedure. 7
For group A (test group):
Inverted periosteal pedicle flap will be carried out as follows according to Shetty 2014:
Patients will be explained about the procedure. Non-surgical phase will include supragingival scaling and root planning, followed by oral hygiene instructions.
The surgical procedure will be carried out three weeks after non-surgical phase as follows:
- Horizontal incisions will be made perpendicular to the adjacent papillae at the level of the cement-enamel junction (CEJ) preserving the gingival margin of the affected teeth.
- Sulcular incisions on the buccal/facial aspect of the involved teeth.
- Vertical incisions extending beyond the mucogingival junction will be made at the line angles of the distal most and the mesial most teeth.
- A partial thickness flap will then be elevated till an adequate amount of periosteum is exposed.
- A horizontal incision will then be given at the apical extent of the periosteum where it is still attached to the bone.
- The periosteum will then be separated from the underlying bone and reflected coronally to an extent where it is still attached to the bone.
- The reflected periosteum will then be inverted such that the cambium layer covers the denuded root.
- Once the periosteum is in place, it is sutured and secured.
- The reflected partial thickness flap will be coronally advanced such that it covers the periosteum and will be sutured using a sling suture.
- The vertical incision will be sutured using an interrupted suture. 8
For group B (control group):
Coronally advanced flap with subepithelial connective tissue graft will be carried out; an envelope flap design will be used according to Zucchelli \& De Sanctis 2000 as follows:
- An intrasulcular incision will be performed involving at least one tooth mesial and at least one tooth distal to the teeth with gingival recessions.
- Oblique incisions will be traced at the interdental soft tissue level to achieve a coronal rotation of the surgical papilla.
- The flap will be then raised up to the mucogingival junction (MGJ) with a periosteal elevator and mobilized with a sharp horizontal periosteal incision beyond the MGJ.
- Exposed root surfaces will be carefully treated with gentle root planing.
- The anatomic interdental papillae will be carefully de-epithelialized.
- The split-full-split thickness flap will be then passively positioned above the CEJ of the involved teeth and interrupted or sling sutures were positioned to achieve optimal buccal flap adaptation.
- The connective tissue graft will be harvested from the palate using the trap door technique (Langer \& Langer 1985), adapted to cover each exposed root about 1 mm beyond the CEJ, and stabilized with resorbable sutures.
- The flap will be then coronally sutured using sling or interrupted sutures.
Post-surgical protocol (Pini-Prato et al.,2010 and Cairo et al., 2016) :
Participants for both groups will be instructed to:
- Intermittently apply an ice bag for the first 4 hours.
- Take ibuprofen 600 mg at the end of the surgical procedure and will be instructed to take another tablet 6 h later and additional doses if needed.
- Avoid any mechanical trauma and tooth-brushing for 3 weeks in the surgical area.
- Smokers will be reminded to quit smoking during the trial time (6 months).
- Chlorexidine rinses will be prescribed twice daily for 1 min. seven days after the surgery.
- Sutures will be removed and prophylaxis will be performed. 9
- About 3 weeks after surgery, patients will be instructed to resume mechanical tooth-cleaning.
Follow up strategy:
Patients will be recalled after 3and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Included participants will be: 1. Gender: Male and Female 2. Age: >20 years 3. Have RT1 and RT2 gingival recession Exclusion criteria: 1. Medically compromised 2. History of certain medications 3. Pregnant females 4. Periapical involvement in selected teeth 5. History of periodontal surgery involving experimental teeth 6. If the problem was due to orthodontic treatment
| Arm | Type | Receives |
|---|---|---|
| Grpup A (Test group) | Experimental | Procedure: Inverted periosteal pedicle flapInverted periosteal pedicle flap will be carried out |
| Group B (Control group) | Active comparator | Procedure: Inverted periosteal pedicle flapCoronally advanced flap with subepithelial connective tissue graft |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gender: Male and Female
- Age: >20 years
- Have RT1 and RT2 gingival recession
Key exclusion criteria (6 listed)
- Medically compromised
- History of certain medications
- Pregnant females
- Periapical involvement in selected teeth
- History of periodontal surgery involving experimental 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 |
|---|---|---|
| Inverted periosteal pedicle flapThe periosteum will be used as an autogenous graft after raising a partial thickness flap in group A | Procedure or surgery | Group B (Control group), Grpup A (Test group) |
Primary outcome
Post-operative discomfort
Time frame: 3 weeks
Numerical using Visual analogue scale (VAS) Questionnaire
4 secondary outcomes
Amount of root coverage
Time frame: 3 months and 6 months
Probing depth
Time frame: 3 months and 6 months
esthetics
Time frame: 6 months
patient's satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Yes. publishing in an international journal
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inverted periosteal pedicle flap in people with Gingival Recession, run by Marwa El Sayed Abbas Ahmed 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 3 inclusion and 6 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 Jan 2020. 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 Marwa El Sayed, Ass. lec. (00201092221005, drmarwah82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative discomfort (time frame: 3 weeks). 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 13 Jan 2020.