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NCT Number: NCT06940050

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

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.)

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Key information

Conditions

Gingival Recession, Localized Gingival Diseases Gingival Recession Gingival Recession, Mucogingival Surgery Gingival Recession, Plastic Surgery Gingival Recessions Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Implantology of Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

Location contact

Véronique Prof. Dr. Christiaens

CONTACT

[email protected]

+32 332 40 17

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years old
  • good oral hygiene
  • presence of at least 2 recessions in the premandible
  • good general health

Exclusion criteria

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

Treatment and study plan

Coronally advanced flap with a connective tissue graft

Procedure

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

Other names: CAF + CTG

tunneled coronally advanced flap with a connective tissue graft

Procedure

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

Other names: TCAF + CTG

Primary outcomes

  1. mean root coverage

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

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

Secondary outcomes

  1. complete root coverage

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

    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.

  2. pocket depth

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

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

  3. recession reduction

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

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

  4. width of keratinized tissue

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

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

  5. gingival thickness

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

    Thickness of the gingival tissue measured 1-2 mm apical to the gingival margin.

  6. phenotype

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

    thin, thick or combined

  7. treatment time

    Time frame: Only measured during surgery in minutes.

    Time in minutes from the first incision till the last suture.

  8. post-operative pain at donor site

    Time frame: From one week post-operative till three months post-operative.

    Post-operative pain at the donor site will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.

  9. post-operative pain at lower front

    Time frame: From one week post-operative till three months post-operative.

    Post-operative pain at lower front will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.

  10. number of analgesics

    Time frame: From one week post-operative till two weeks post-operative.

    The number of pain medication tablets consumed by the patient to manage post-operative pain.

  11. score of aesthetic result

    Time frame: From six months post-operative till ten years post-operative.

    Aesthetic satisfaction based on root coverage and color match.

  12. root sensitivity

    Time frame: From one week pre-operative till ten years post-operative.

    Root sensitivity is assessed using the Visual Analogue Scale (VAS), ranging from 0 (no sensitivity) to 10 (extreme sensitivity), based on a tactile test with controlled air flow. A higher score indicates that the patient experiences greater sensitivity.

  13. willingness to retreatment

    Time frame: From three months post-operative till two years post-operative.

    A patient's willingness to undergo retreatment based on their previous experience with the procedure. It is assessed by using the Visual Analogue Scale ranging from 0 (not willing at all) to 10 (extremely willing). A patient reporting a higher score indicates greater willingness.

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique Prof. Dr. Christiaens

CONTACT

[email protected]

+32 332 40 17

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Mediplus Ltd UK

Registry information

Official study title

An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.

Important dates

Study start
2025
Primary completion
2036
Study completion
2037
First posted
Apr 23, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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