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Completed

NCT Number: NCT03497403

Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.

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Key information

Conditions

Ridge Preservation Bone Regeneration

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

About this study

The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline & 6-months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • between 20-80 years of age
  • healthy with no conditions that could alter wound healing
  • requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
  • a tooth requiring extraction that is treatment planned for implant placement
  • willing to participate in the study and sign the informed consent
  • willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.

Exclusion criteria

  • systemic conditions which could alter wound healing
  • tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
  • severe local infection at extraction site
  • a tooth exhibiting severe resorption of buccal or lingual plates
  • absence of keratinized tissue buccal to the tooth to be extracted
  • severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.

Treatment and study plan

Socket preservation control

Procedure

After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.

Socket preservation experimental

Procedure

After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.

Primary outcomes

  1. Keratinized tissue width

    Time frame: 6 months

    Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.

Secondary outcomes

  1. Keratinized tissue thickness

    Time frame: 6 months

    Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.

  2. Vestibular Depth

    Time frame: 6 months

    The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.

  3. CEJ-FGM

    Time frame: 6 months

    The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe.

  4. Ridge Width

    Time frame: 6 months

    After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.

  5. CEJ- Buccal crest

    Time frame: 6 months

    The distance from the tooth's cervical enamel junction and the top of the buccal bone crest was taken with a probe.

  6. CBCT bone height

    Time frame: 6 months

    CBCT scans were taken and the alveolar ridge height was then measured.

  7. CBCT bone width

    Time frame: 6 months

    CBCT scans were taken and the alveolar ridge width was then measured.

  8. Cast ridge width

    Time frame: 6 months

    Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.

  9. Cast ridge volume

    Time frame: 6 months

    Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.

Sponsors and collaborators

Lead sponsor

Harvard School of Dental Medicine

Other

Collaborators

  • Valeant Pharmaceuticals

Registry information

Official study title

Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2018
Registry last updated
Apr 13, 2018

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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