An interventional study of Periodontal regenerative surgery with bioactive glass alone and Periodontal regenerative surgery with bioactive glass and a collagen membrane in Periodontitis, sponsored by Medical University of Bialystok. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Treatment
Periodontitis can cause loss of the bone supporting the teeth. Regenerative surgery aims to repair these defects and improve tooth support. Bioactive glass is a synthetic bone graft material used to fill periodontal bone defects. A resorbable collagen membrane may be placed over the graft to support healing, but its additional long-term benefit remains uncertain.
This randomized clinical trial compared bioactive glass alone with bioactive glass covered by a resorbable collagen membrane in 40 participants with periodontal intrabony defects. Both groups underwent surgical cleaning of the defects before placement of the assigned materials. Clinical measurements were performed by an examiner who was unaware of treatment allocation.
Assessments were conducted before surgery, at 6 months, and at approximately 12 years. They included periodontal pocket depth, clinical attachment level, gum recession, plaque and bleeding scores, and defect dimensions measured on dental radiographs. Seventeen participants attended the 12-year examination. The study evaluated whether treatment improvements were maintained over time and whether adding a collagen membrane provided additional benefit.
This single-center, randomized, parallel-group clinical trial evaluated the clinical and radiographic outcomes of regenerative surgery for periodontal intrabony defects using bioactive glass alone or in combination with a resorbable collagen membrane. The study was conducted at the Department of Periodontal and Oral Mucosa Diseases, Medical University of Bialystok, Poland. The objective was to compare the two treatment approaches at 6 months and assess the stability of treatment outcomes approximately 12 years after surgery.
Forty participants were enrolled between June 2011 and January 2013. Eligible participants had at least one periodontal intrabony defect with a radiographic depth of at least 3 mm, a radiographic width of at least 2 mm, and an associated probing depth of at least 5 mm. Before surgery, participants were required to demonstrate adequate plaque and inflammation control, defined as full-mouth plaque and bleeding on probing scores below 20%.
Participants were assigned to two treatment groups by simple randomization using a pregenerated Microsoft Excel randomization table. One group received bioactive glass alone (GlassBONE; NORAKER, Lyon, France). The other group received the same bioactive glass combined with a resorbable collagen membrane (CopiOs Pericardium Membrane; Tutogen Medical GmbH, Neunkirchen am Brand, Germany).
All participants underwent scaling and root planing 1 week before surgery. Surgical procedures were performed under local anesthesia by the same experienced surgeon. A simplified or modified papilla preservation technique was selected according to interdental papilla anatomy. Following elevation of a full-thickness mucoperiosteal flap, granulation tissue was removed and the root surface was debrided. The defect was then filled with bioactive glass. In the combination group, a collagen membrane was trimmed and adapted to cover the graft and adjacent bone. Flaps were repositioned to cover the treated defects and secured with non-resorbable sutures.
The perioperative regimen included amoxicillin, 1 g twice daily for 8 days, and ibuprofen, 400 mg up to three times daily as needed for postoperative pain. Early postoperative visits were conducted at 1, 2, 4, and 8 weeks and at 3 and 6 months. Sutures were removed after 2 weeks. Participants subsequently attended routine annual dental check-ups.
Standardized clinical and radiographic assessments were performed before surgery, at 6 months, and approximately 12 years after surgery. Clinical measurements were obtained by the same calibrated examiner, who was blinded to treatment allocation. Assessments included probing depth, clinical attachment level, gingival recession, full-mouth plaque score, and full-mouth bleeding on probing score. Site-specific plaque and bleeding were also evaluated. Clinical measurements were obtained using a PCP-UNC15 periodontal probe.
Radiographic assessments evaluated the height and width of the treated intrabony defects on intraoral periapical radiographs. Conventional film radiographs were obtained at baseline, while digital radiographs were obtained at the follow-up examinations. The paralleling technique and individualized positioning devices with bite registrations were used to improve reproducibility of projection geometry across examinations.
The approximately 12-year follow-up examinations were conducted between June 2023 and January 2025. Seventeen of the original 40 participants attended this assessment: eight in the bioactive glass alone group and nine in the bioactive glass plus collagen membrane group. Longitudinal assessments compared baseline, 6-month, and 12-year measurements to evaluate changes within each treatment group and differences between the treatment approaches.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's enrollment of 40 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.
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At least one periodontal intrabony defect with a radiographic depth of at least 3 mm and a radiographic width of at least 2 mm.
Probing depth of at least 5 mm at the site associated with the defect.
No systemic diseases that could affect surgical treatment or tissue healing.
No long-term pharmacotherapy.
Full-mouth plaque score below 20% and full-mouth bleeding on probing score below 20%.
Exclusion Criteria:
Systemic diseases that could affect eligibility for surgery or healing, including uncontrolled diabetes, uncontrolled hypertension, and severe cardiovascular disease.
Osteoporosis treated with bisphosphonates or other antiresorptive medications.
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Pregnancy or breastfeeding.
Allergy to penicillins.
Confirmed or suspected to any of the biomaterials used in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants underwent surgical treatment of periodontal intrabony defects using bioactive glass alone (GlassBONE; NORAKER, Lyon, France). Following elevation of a papilla preservation flap, removal of granulation tissue, and root surface debridement, the defect was filled with bioactive glass. The flap was repositioned to cover the graft and secured with non-resorbable sutures.
Procedure: Periodontal regenerative surgery with bioactive glass alone
Participants underwent surgical treatment of periodontal intrabony defects using bioactive glass (GlassBONE; NORAKER, Lyon, France) combined with a resorbable collagen membrane (CopiOs Pericardium Membrane; Tutogen Medical GmbH, Neunkirchen am Brand, Germany). Following elevation of a papilla preservation flap, removal of granulation tissue, and root surface debridement, the defect was filled with bioactive glass. The collagen membrane was trimmed and adapted to cover the graft and adjacent bone. The flap was repositioned to completely cover the membrane and secured with non-resorbable sutures.
Procedure: Periodontal regenerative surgery with bioactive glass and a collagen membrane
Following elevation of a papilla preservation flap, granulation tissue was removed and the root surface was debrided. The periodontal intrabony defect was filled with GlassBONE bioactive glass (NORAKER, Lyon, France). The flap was repositioned to cover the graft and secured with non-resorbable sutures. No barrier membrane was used.
Following elevation of a papilla preservation flap, granulation tissue was removed and the root surface was debrided. The periodontal intrabony defect was filled with GlassBONE bioactive glass (NORAKER, Lyon, France). A resorbable CopiOs Pericardium Membrane (Tutogen Medical GmbH, Neunkirchen am Brand, Germany) was trimmed and adapted to cover the graft and adjacent bone. The flap was repositioned to completely cover the membrane and secured with non-resorbable sutures.
Change in Clinical Attachment Level
Clinical attachment level (CAL) was measured in millimeters as the distance from the cementoenamel junction to the bottom of the periodontal pocket at the treated intrabony defect site using a PCP-UNC15 periodontal probe. Measurements were performed by a calibrated examiner blinded to treatment allocation. Changes were calculated relative to baseline. A decrease in CAL indicates clinical attachment gain.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
Change in Probing Depth
Probing depth (PD) was measured in millimeters from the gingival margin to the bottom of the periodontal pocket using a PCP-UNC15 periodontal probe. The greatest probing depth within the pocket corresponding to the treated intrabony defect was recorded. Changes were assessed relative to baseline. A decrease indicates improvement.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
Change in Gingival Recession
Gingival recession (GR) was measured in millimeters from the cementoenamel junction to the gingival margin using a PCP-UNC15 periodontal probe. Positive values indicated a gingival margin located apical to the cementoenamel junction. Changes at the treated site were assessed relative to baseline. An increase indicates greater recession.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
Change in Full-Mouth Plaque Score
Full-mouth plaque score (FMPS) was calculated as the percentage of examined sites with detectable plaque, assessed at six sites around each tooth present. Scores range from 0% to 100%, with higher values indicating more plaque. Changes were assessed relative to baseline.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
Change in Radiographic Intrabony Defect Height
Radiographic intrabony defect height (Rx-OH) was measured in millimeters on standardized intraoral periapical radiographs. Changes were assessed relative to baseline. A decrease indicates a reduction in the radiographic vertical dimension of the defect.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
Change in Radiographic Intrabony Defect Width
Radiographic intrabony defect width (Rx-OW) was measured in millimeters on standardized intraoral periapical radiographs. Changes were assessed relative to baseline. A decrease indicates a reduction in the radiographic horizontal dimension of the defect.
Time frame: Baseline (before surgery), 6 months and 12 years after surgery.
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Medical University of Bialystok