IPPF: Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession

Sponsor

Marwa El Sayed Abbas Ahmed (Other)

Overall Status

Unknown status

CT.gov ID

NCT03701191

Collaborator

Cairo University (Other)

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Procedure: Inverted periosteal pedicle flap	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 treatmentIncluded participants will be:Gender: Male and Female Age: >20 years Have RT1 and RT2 gingival recessionExclusion 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

Masking:

Single (Outcomes Assessor)

Masking Description:

Two outcome assessors will be chosen: one will be a periodontist but not included within the research; and the other will be a non-periodontist. The outcome assessors will be blinded; they will not be informed by the type of intervention to be assessed.

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jan 25, 2020

Anticipated Primary Completion Date :

Feb 28, 2020

Anticipated Study Completion Date :

Aug 28, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post-operative discomfort [3 weeks]
Numerical using Visual analogue scale (VAS) Questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university, Faclty of dentistry	Cairo		Egypt

Sponsors and Collaborators

Marwa El Sayed Abbas Ahmed
Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa El Sayed Abbas Ahmed, Assistant Lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03701191

Other Study ID Numbers:

perio 2:5:1

First Posted:

Oct 9, 2018

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marwa El Sayed Abbas Ahmed, Assistant Lecturer, Cairo University

gingival recession, periosteum, autogenous graft

Additional relevant MeSH terms:

Gingival Recession

Study Results

No Results Posted as of Jan 13, 2020