Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession (IPPF)

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).

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Inverted periosteal pedicle flap

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

11. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo university, Faclty of dentistry
    • Contact: Ahmed Re Abd El Raman, Ass. Prof.; Phone Number: 00201006608568; Email: dr.a.reda@gmail.com
    • Contact: Mona Sa Darhous, Professor; Phone Number: 00201223155955; Email: mona.darhous@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grpup A (Test group); Inverted periosteal pedicle flap will be carried out	Procedure: Inverted periosteal pedicle flap; The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A
Active Comparator: Group B (Control group); Coronally advanced flap with subepithelial connective tissue graft	Procedure: Inverted periosteal pedicle flap; The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative discomfort	Numerical using Visual analogue scale (VAS) Questionnaire	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of root coverage	continuous (mm)	3 months and 6 months
Probing depth	continuous (mm)	3 months and 6 months
esthetics	numerical using Root coverage esthetic score (RES)	6 months
patient's satisfaction	categorical via assessment of patient-related criteria using a 3-point rating scale	6 months

Collaborators and Investigators

• Sponsor: Marwa El Sayed Abbas Ahmed
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2020
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): August 28, 2020

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: gingival recession, periosteum, autogenous graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: perio 2:5:1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: publishing in an international journal
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No