Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.

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 are : tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a rather recent developed surgical approach.

This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. 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 coronally advanced flap (CAF = the gum is detached and repositioned higher) 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.

Participants will:

* Undergo surgery (CAF 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 at least 2 recessions 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

  • Coronally advanced flap with a connective tissue graft

    Procedure/Surgery

    The gum at the recession site is detached and reattached higher (combined with a connective tissue graft).

  • Tunneled coronally advanced flap with a connective tissue graft

    Procedure/Surgery

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: TCAF + CTGActive comparator 1 intervention
Group B: CAF + 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 till 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 till ten years after surgical treatment.
2

pocket depth

The distance from the gingival margin to the bottom of the sulcus measured using a periodontal probe.

Time frame
From enrollment till ten years after surgical treatment.
3

recession reduction

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

Time frame
From enrollment till 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 with a periodontal probe.

Time frame
From enrollment till ten years after surgical treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Mediplus Ltd UK

Collaborator