Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure

NCT06871735 | Recruiting

• 1 other identifier: 2023H0107
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted. An incision is made, bone grafting material is placed in that spot, there is a membrane put over it as a barrier, then gum tissue has to be pulled back over it. Usually, this is enough to cover the whole wound, but sometimes the barrier membrane can't be covered with tissue the whole way without too much pulling, and the barrier membrane is still exposed. In that case, one thing that can be done is to place another material, an acellular collagen matrix, over the barrier membrane and secure it there. This material has been shown to help with the healing in these cases. Participants in this study will be clinic patients who have been determined to need a GBR procedure. Participants will get the GBR. If the barrier membrane is still exposed, then the acellular matrix material will be placed. This study will compare the healing outcomes and the success of the GBR depending on whether the acellular matrix material was used. The procedure itself is not part of the study. The only people in the study are patients who are already planning to have this procedure done as part of their dental care. It is important to note that the research study will not affect the care that the patient is given, or whether or not the acellular matrix material is used. That will be decided by the dental surgeon who is treating them, based on their clinical judgement. The research study will only observe and compare the outcomes. For the study, participants will have some additional clinical measurements made, besides the ones that are done as part of the follow-up care, and will be asked questions about their experience.

Conditions

Bone Graft

Keywords

GBR; Bone graft; dental implant

Outcome Measures

Primary Outcomes (4)

• Healing Score Index 8-10 days

  Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At first PO appointment

  8-10 days following the surgical procedure

• Healing Score Index 6-8 weeks

  Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At second PO appointment

  6-8 weeks following the surgical procedure

• Wound Healing 8-10 days

  Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At first PO appointment

  8-10 days following the surgical procedure

• Wound Healing 6-8 weeks

  Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At second PO appointment

  6-8 weeks following the surgical procedure

Secondary Outcomes (5)

• Change in ridge dimension

  Day of surgery, 1st PO appt (8-10 days post surgery), 2nd PO appointment (6-8 weeks post surgery), final appointment (4-6 months post surgery)

• Patient experience - surgery

  Day of surgical procedure

• Patient experience - 8-10 days PO

  8-10 days following the surgical procedure

• Patient experience - 6-8 weeks PO

  6-8 weeks following the surgical procedure

• Patient experience - implant appointment

  4-6 months following the surgical procedure

Study Arms (2)

With acellular matrix

Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound

Procedure: Acellular matrix

Surgical closure

Participants who are having the GBR procedure done by having the wound closed without the acellular material

Procedure: Surgical closure

Interventions

Acellular matrix PROCEDURE

Wound closure is obtained by use of acellular matrix material placed over the exposed barrier membrane. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.

With acellular matrix

Surgical closure PROCEDURE

Wound from the graft is surgically closed, with no use of the acellular matrix. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.

Surgical closure

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are patients at the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who have been treatment-planned for a guided bone regeneration procedure prior to dental implant.

You may qualify if:

• Have a missing tooth or teeth which are planned to be replaced with an implant
• Need for guided bone regeneration procedure to increase the bone available for implant placement
• Systemically healthy with no contraindications for bone grafting and/or implant surgery
• No chronic sinus problems
• Non-smoker
• No need for removable temporary restorations during wound healing.

You may not qualify if:

• Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure
• Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours
• The need to wear a removable temporary restoration during healing

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Graduate Periodontics Clinic

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Interventions

Wound Closure Techniques

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Binnaz Leblebicioglu, DDS, MS, PhD

CONTACT

614-292-0371; leblebicioglu.1@osu.edu

Francesca Racca, DMD

CONTACT

(614) 292-0371; racca.2@osu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: April 13, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)