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.
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
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
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.
Case-control
Prospective
Acellular matrix
Procedure/SurgeryWound 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.
Surgical closure
Procedure/SurgeryWound 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.
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
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
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
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
Change in ridge dimension
Ridge height and width, measured using the surgical template
Patient experience - surgery
* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe) * Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) Any postsurgical issues reported
Patient experience - 8-10 days PO
* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe) * Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) * Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) * The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days) * Any postsurgical issues reported At first post-op appointment
Patient experience - 6-8 weeks PO
* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe) * Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) * Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) * The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days) * Any postsurgical issues reported At second post-op appointment
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