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The Use of Mucograft® to Treat Gingival Recession

Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02986191
Enrollment
20
Registered
2016-12-08
Start date
2016-08-31
Completion date
2017-12-20
Last updated
2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

gingival graft, free gingival graft, coronally advanced flap, reduced keratinized gingiva

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.

Interventions

PROCEDUREMucograft

This method of grafting will be used to treat the gingival recession using coronally advanced flaps.

PROCEDUREConnective Tissue Graft

This will be used in the traditional manner to correct gingival recession

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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-operativelyClinical 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

MeasureTime frameDescription
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-operativelyProbing 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-operativelyGingival 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-operativelyGingival 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-operativelyThe 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-operativelyThe 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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026