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The Use of Mucograft® to Treat Gingival Recession

Not Applicable
Completed
Conditions
Gingival Recession
Interventions
Procedure: Mucograft
Procedure: Connective Tissue Graft
Registration Number
NCT02986191
Lead Sponsor
Damascus University
Brief Summary

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Detailed Description

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Presence of Type I or II (Miller Classification) of gingival recession
Exclusion Criteria
  • Smoking
  • Pregnancy or lactating
  • Presence of any systematic diseases can affect the periodontal surgery.
  • Subjects with significant moderate to severe periodontal disease.
  • Patients under orthodontic treatment
  • Presence of restorative materials (e.g. crown)
  • Effectiveness of frenum
  • Subjects have failed to maintain good plaque control.
  • Subjects having previous surgical treatment for covering the recession in the chosen area.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
MucograftMucograftOne side of the mouth will be subjected to Mucograft in this split-mouth study design.
Connective tissue graftConnective Tissue GraftThe opposite side of the mouth will be subjected to a connective tissue graft.
Primary Outcome Measures
NameTimeMethod
Change in the Clinical Attachment Level IndexMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.

Secondary Outcome Measures
NameTimeMethod
Change in Probing DepthMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Probing depth is going to be measuring using a specific tool (UNC-15 probe).

Change in Gingival RecessionMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

Change in Gingival BiotypeMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).

Change in Root Coverage IndexMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

The amount of root exposure will be measured and compared to the total length of the root

Change in Resistance to Muscular PullMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.

Change in Color Match IndexMeasurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Shrinkage index at three monthsMeasurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.
Shrinkage index at six monthsMeasurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.

Trial Locations

Locations (1)

Department of Periodontics, University of Damascus Dental School

🇸🇾

Damascus, Syrian Arab Republic

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