NCT02269748

Brief Summary

The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT). The primary objective of the study is to demonstrate the superiority in terms of the post-operative course and pain of the CAF+SeCTG when compared to the TT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

October 15, 2014

Last Update Submit

October 17, 2014

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Patient morbidity

    Quantity of analgesics taken during the first week post-surgery. Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.

    3 days after intervention

Secondary Outcomes (4)

  • Clinical measurements GH

    12 months follow-up

  • Clinical measurements PD

    12 months follow-up

  • Clinical measurements CAL

    12 months follow-up

  • Clinical measurements KTH

    12 months follow-up

Study Arms (2)

Root coverage with Tunnel (TT)

EXPERIMENTAL

The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface

Procedure: Tunnel technique with subepithelial connective tissueDrug: Analgesic Therapy

Coronally advanced flap (CAF+SeCTG)

ACTIVE COMPARATOR

The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface

Procedure: Coronally advanced flapDrug: Analgesic Therapy

Interventions

Tunnel technique with subepithelial connective tissuePROCEDURE

After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.

Also known as: root coverage procedure with tunnel technique
Root coverage with Tunnel (TT)
Coronally advanced flapPROCEDURE

After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally

Also known as: Coronally advanced flap with sub epithelial connective tissue graft
Coronally advanced flap (CAF+SeCTG)
Analgesic TherapyDRUG

Ibuprofen 600 mg TID

Coronally advanced flap (CAF+SeCTG)Root coverage with Tunnel (TT)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.

You may not qualify if:

  • Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.
  • Molar teeth will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, PD, 35122, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Faculty Department of Periodontology

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 21, 2014

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

IT(1)