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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Marwa El Sayed, Ass. lec. contact

00201092221005

drmarwah82@yahoo.com

Ahmed Re da Abd EL Rahman, Ass. Prof. contact

00201006608568

dr.a.reda@gmail.com

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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:

  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
  7. 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:

  1. 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.
  2. Sulcular incisions on the buccal/facial aspect of the involved teeth.
  3. Vertical incisions extending beyond the mucogingival junction will be made at the line angles of the distal most and the mesial most teeth.
  4. A partial thickness flap will then be elevated till an adequate amount of periosteum is exposed.
  5. A horizontal incision will then be given at the apical extent of the periosteum where it is still attached to the bone.
  6. The periosteum will then be separated from the underlying bone and reflected coronally to an extent where it is still attached to the bone.
  7. The reflected periosteum will then be inverted such that the cambium layer covers the denuded root.
  8. Once the periosteum is in place, it is sutured and secured.
  9. The reflected partial thickness flap will be coronally advanced such that it covers the periosteum and will be sutured using a sling suture.
  10. 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:

  1. An intrasulcular incision will be performed involving at least one tooth mesial and at least one tooth distal to the teeth with gingival recessions.
  2. Oblique incisions will be traced at the interdental soft tissue level to achieve a coronal rotation of the surgical papilla.
  3. 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.
  4. Exposed root surfaces will be carefully treated with gentle root planing.
  5. The anatomic interdental papillae will be carefully de-epithelialized.
  6. 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.
  7. 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.
  8. 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:

  1. Intermittently apply an ice bag for the first 4 hours.
  2. 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.
  3. Avoid any mechanical trauma and tooth-brushing for 3 weeks in the surgical area.
  4. Smokers will be reminded to quit smoking during the trial time (6 months).
  5. Chlorexidine rinses will be prescribed twice daily for 1 min. seven days after the surgery.
  6. Sutures will be removed and prophylaxis will be performed. 9
  7. 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.

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 groups in NCT03701191
Study groupRoleWhat they receive
Grpup A (Test group)ExperimentalInverted periosteal pedicle flap will be carried out
Receives: Procedure: Inverted periosteal pedicle flap
Group B (Control group)Active comparatorCoronally 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.

  1. Post-operative discomfort

    Numerical using Visual analogue scale (VAS) Questionnaire

    Measured: 3 weeks

Secondary outcomes (4)
  1. Amount of root coverage

    continuous (mm)

    Measured: 3 months and 6 months

  2. Probing depth

    continuous (mm)

    Measured: 3 months and 6 months

  3. esthetics

    numerical using Root coverage esthetic score (RES)

    Measured: 6 months

  4. 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.

  1. First posted9 Oct 2018
  2. Study start25 Jan 2020 (estimated)
  3. Primary completion28 Feb 2020 (estimated)
  4. Study completion28 Aug 2020 (estimated)

Resources

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)
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

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.

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