NCT05448040

Brief Summary

The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal \[MS\], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

June 24, 2022

Last Update Submit

July 1, 2022

Conditions

Socket SealingFree Gingival GraftCollagen Membrane

Keywords

Alveolar sealingFree gingival graftAutogenous graftCollagen matrix

Outcome Measures

Primary Outcomes (1)

  • Radiographic and clinical analysis

    Socket preservation with xenograft biomaterial and another one to seal it (FGG or collagen membrane). Radiographic analysis - PA (periapical x-rays) comparing groups and periods of the follow-up. It was performed descriptive comparative analysis. Clinical evaluation - bleeding on probing (dichotomic analysis), ISQ (torque achieved - Osstell), qualitative analysis (questionnaire with 8 questions), and subjective appraisal of the soft tissue healing (according to the period of evaluation).

    6 months

Secondary Outcomes (1)

  • Histological analysis - Gingiva

    6 months

Study Arms (2)

Collagen

EXPERIMENTAL

This group received a bone graft (xenograft) and had the socket covered with a collagen membrane, in order to protect the bone graft inserted and seal the socket.

Procedure: Socket preservation

Free gingival graft

EXPERIMENTAL

This group received a bone graft (xenograft) biomaterial and had the socket covered with a free gingival graft material, in order to protect the bone graft inserted and seal the socket.

Procedure: Socket preservation

Interventions

Socket preservationPROCEDURE

Tooth extraction and preservation with a biomaterial

CollagenFree gingival graft

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients ASA I
  • patients requiring single tooth extraction in the site between #4 to #13
  • patients without enough bone volume for immediate implant placement.

You may not qualify if:

  • patients with general contraindications for implant surgery
  • pregnant or lactating women
  • patients with untreated periodontitis
  • bruxism or severe clenching
  • immunosuppressed
  • patients with a previous history of irradiation of the head and neck area
  • uncontrolled diabetes
  • heavy smoker (\>10 cigarettes/day)
  • poor oral hygiene and low motivation
  • use of bisphosphonates
  • substance abuse such as alcohol or drugs and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UM - POM Dpt

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Joly, PhD

    Sao Leopoldo Mandic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 7, 2022

Study Start

February 1, 2018

Primary Completion

September 18, 2020

Study Completion

November 30, 2021

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

No.

Locations

US(1)