Influence of suture on the fixation of a volume-stable collagen matrix in multiple root coverage - A randomized clinical trial

Influence of the suture technique on the tissue volume obtained with a volume-stable collagen matrix in gingival recessions – a randomized clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9cxtns2

Enrollment

Unknown

Registered

2025-10-01

Start date

2023-04-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Gingival recession

Interventions

This is a randomized clinical trial with two parallel groups. Forty eight individuals presenting with type 1 gingival recession in three adjacent teeth in the maxilla or mandible will be randomly allo

E07.862.710

E07.858.690.820

D25.130

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals of both sexes. Aged 18 years or older. Presence of RT1 gingival recessions in incisors, canines, or premolars in the maxilla or mandible. Multiple and adjacent recessions in three teeth with a depth difference of no more than 2 millimeters between the recessions. Presence of keratinized tissue greater than or equal to 1 millimeter in the involved teeth. Visible cemento-enamel junction

Exclusion criteria

Exclusion criteria: Active periodontal disease or history of periodontal disease in the candidate teeth. Malpositioned teeth in the recipient area including buccal displacement, rotation, or occlusal trauma. Presence of root caries. Non-carious cervical lesions or cervical step greater than 1 millimeter. Smoking more than 10 cigarettes per day. Pregnant or lactating women. Systemic diseases that may interfere with tissue healing such as diabetes mellitus or acquired immunodeficiency syndrome

Design outcomes

Primary

Measure	Time frame
Clinical tissue thickness of the tooth that received the collagen matrix during the surgical procedure. This variable will be measured using an endodontic finger spreader and a silicone stop positioned 1.5 millimeters apical to the gingival margin. After topical anesthesia, the spreader will be inserted perpendicular to the alveolar bone and the stop will be gently positioned on the gingiva. The distance between the tip of the spreader and the stop will be recorded using a digital caliper. Thickness will be measured before surgery and at six months, one year, three years and five years postoperatively. A gain of at least 0.5 millimeter will be considered clinically relevant	—

Measure

Time frame

Clinical tissue thickness of the tooth that received the collagen matrix during the surgical procedure. This variable will be measured using an endodontic finger spreader and a silicone stop positioned 1.5 millimeters apical to the gingival margin. After topical anesthesia, the spreader will be inserted perpendicular to the alveolar bone and the stop will be gently positioned on the gingiva. The distance between the tip of the spreader and the stop will be recorded using a digital caliper. Thickness will be measured before surgery and at six months, one year, three years and five years postoperatively. A gain of at least 0.5 millimeter will be considered clinically relevant

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Secondary

Measure	Time frame
Assessment of gingival phenotype through the visibility of the periodontal probe inserted into the sulcus and using a color-coded periodontal probe. The variable will be collected before surgery and at three months, six months, one year, three years and five years after the procedure ;To evaluate the linear gingival thickness of the tooth that received the collagen matrix through the superimposition of STL files obtained before surgery and three months after the procedure. The analysis will be performed using imaging software based on the sagittal section of the center of the treated tooth. The measurement will be taken at 1.5 millimeters from the gingival margin. Thickness gain will be compared between groups subjected to different collagen matrix suture techniques. A gingival thickness gain equal to or greater than 0.5 millimeter is expected;Assessment of postoperative pain perception using a visual analog scale from zero to ten, where zero indicates no pain and ten indicates severe pain. The questionnaire will be administered at all follow-up visits during the first month after surgery ;The impact of the procedure on individuals' daily activities will be assessed using the OHIP-14 questionnaire, which will be administered both before surgery and at all post-surgical follow-up appointments;Assessment of visible plaque on the treated teeth using the visible plaque index. Data will be collected before surgery and at three months, six months, one year, three years and five years after the procedure ;Assessment of probing depth in millimeters from the gingival margin to the bottom of the gingival sulcus. Measurements will be performed before surgery and at three months, six months, one year, three years and five years after the procedure ;Assessment of bleeding on probing recorded as positive when bleeding occurs within ten seconds after periodontal probing. The variable will be collected before surgery and at three months, six months, one year, three years and fi	—

Measure

Time frame

Assessment of gingival phenotype through the visibility of the periodontal probe inserted into the sulcus and using a color-coded periodontal probe. The variable will be collected before surgery and at three months, six months, one year, three years and five years after the procedure ;To evaluate the linear gingival thickness of the tooth that received the collagen matrix through the superimposition of STL files obtained before surgery and three months after the procedure. The analysis will be performed using imaging software based on the sagittal section of the center of the treated tooth. The measurement will be taken at 1.5 millimeters from the gingival margin. Thickness gain will be compared between groups subjected to different collagen matrix suture techniques. A gingival thickness gain equal to or greater than 0.5 millimeter is expected;Assessment of postoperative pain perception using a visual analog scale from zero to ten, where zero indicates no pain and ten indicates severe pain. The questionnaire will be administered at all follow-up visits during the first month after surgery ;The impact of the procedure on individuals' daily activities will be assessed using the OHIP-14 questionnaire, which will be administered both before surgery and at all post-surgical follow-up appointments;Assessment of visible plaque on the treated teeth using the visible plaque index. Data will be collected before surgery and at three months, six months, one year, three years and five years after the procedure ;Assessment of probing depth in millimeters from the gingival margin to the bottom of the gingival sulcus. Measurements will be performed before surgery and at three months, six months, one year, three years and five years after the procedure ;Assessment of bleeding on probing recorded as positive when bleeding occurs within ten seconds after periodontal probing. The variable will be collected before surgery and at three months, six months, one year, three years and fi

—

Countries

Brazil

Contacts

Public ContactJoão Bastista Neto

Universidade de São Paulo

jbcesarneto@usp.br+55 (15) 98127-3300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)