Comparing TCAF and MTUN With Soft Tissue Grafting for Treating Single Recessions in the Premandible

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

Multiple techniques can be used for recession coverage. The most common techniques for single recessions are : tunnel technique (T) and coronally advanced flap (CAF) both combined with a palatal graft to provide sufficient gingival thickness. Recently two modifications have been described in literature, namely the tunneled coronally advanced flap and the modified tunnel. MTUN will function as the control group while people treated with the TCAF technique will function as the test group.

This randomized controlled trial compares MTUN and TCAF to determine which technique provides better root coverage for receding gums at single recession in the premandible. The main question it aims to answer is:

\- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.

Researchers will compare the modified tunnel technique (MTUN = the gum is undermined) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel, is to increase thickness and provide support. Pain associated to the material used to cover the donorsite will be seen as the secondary research question. The site will either be covered by spongostan and multiple stitches or a palatal stent.

Participants will:

* Undergo surgery (MTUN or TCAF, randomly assigned) to cover recessions * Attend regular check-ups for up to 10 years after surgery * Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years old

good oral hygiene

presence of one recession in the premandible

good general health

Disqualifiers

smoker

pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)

Trial design

Design model

Parallel

Treatments tested in this trial

  • tunneled coronally advanced flap with connective tissue graft

    Procedure/Surgery

    The gum at the recession site is undermined, only partially detached and reattached higher (combined withh a connective tissue graft).

  • modified tunnel with connective tissue graft

    Procedure/Surgery

    At the recession site, the gingiva is undermined to create a tunnel, and a connective tissue graft is inserted through the sulcus into this space before advancing the flap coronally.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: TCAF + CTGActive comparator 1 intervention
Group B: MTUN + CTGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

mean root coverage

The average percentage of previously exposed tooth root surface that becomes covered by gingival tissue following a root coverage procedure.

Time frame
From enrollment up to ten years after surgical treatment.

Secondary outcomes

1

complete root coverage

The percentage of teeth for which the previously exposed root surface is completely covered by gingival tissue following the surgical procedure. These teeth show no visible recession after healing.

Time frame
From enrollment up to ten years after surgical treatment.
2

pocket depth

The distance from the gingival margin to the bottom of the sulcus by use of a periodontal probe.

Time frame
From enrollment up to ten years after surgical treatment.
3

recession reduction

The change in the amount of exposed root surface after the root coverage procedure.

Time frame
From enrollment up to ten years after surgical treatment.
4

width of keratinized tissue

The distance from the mucogingival junction to the free gingival margin. It includes free and attached gingival tissue, measured by use of a periodontal probe.

Time frame
From enrollment up to ten years after surgical treatment.

Other outcomes

Sponsors and contacts

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