Alveolar Bone LossNCT07718932
Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction
A study testing Enamel Matrix Derivative (Emdogain®) in people with Alveolar Bone Loss and Periodontal Pocket, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
This study investigates whether the intraoperative application of a specialized regenerative gel (Emdogain®) can improve the periodontal health of the mandibular second molar by preventing or reducing the formation of tissue defects after the surgical removal of an adjacent impacted lower wisdom tooth. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Alveolar Bone Loss, Periodontal Pocket, Impacted Tooth With Abnormal Positioning
- What is being tested?
- Enamel Matrix Derivative (Emdogain®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesGreece
- Study dates
- 9 Mar 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult patients aged 18 to 35 years old (ASA I or II).
- Presence of an asymptomatic, partially or fully impacted mandibular third molar requiring surgical extraction.
- The third molar impaction must be mesioangular or horizontal, with its crown in direct physical contact with the adjacent second molar, as assessed by a preoperative panoramic radiograph.
- The adjacent mandibular second molar must be vital, fully erupted, and structurally sound (free of extensive dental caries or prosthetic crowns).
- Patients must demonstrate an adequate level of overall oral hygiene and gingival health (e.g., Full-Mouth Plaque Index < 20% and Full-Mouth Bleeding Score < 20% following initial prophylaxis and oral hygiene instructions).
- Willingness to comply with postoperative instructions and adhere to the scheduled follow-up visits.
- Ability to understand the study procedures and voluntarily sign the informed consent form.
Who cannot join
- Presence of systemic diseases or conditions that could compromise wound healing or periodontal health (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
- Current or recent use of medications known to affect bone metabolism or wound healing (e.g., bisphosphonates, long-term systemic corticosteroids, immunosuppressants).
- History of heavy smoking (e.g., >10 cigarettes per day) or use of smokeless tobacco products.
- Pregnant or lactating females.
- Diagnosis of periodontitis (Stage II, III, or IV) affecting the remaining dentition, excluding the localized defect associated with the impacted third molar.
- Presence of active acute infection (e.g., purulent pericoronitis) or radiolucent pathologic lesions extending beyond the normal follicular space (e.g., dentigerous cysts) that would significantly alter the baseline bony defect morphology.
- Known allergy or hypersensitivity to any of the medications utilized in the surgical or postoperative protocol (e.g., local anesthetics, prescribed antibiotics, or analgesics).
- Previous orthodontic treatment utilizing bands on the mandibular second molars that could have affected the periodontal attachment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
424 General Military Hospital
Thessaloniki
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki
About this study
Official title: The Role of Enamel Matrix Derivative in Reducing the Periodontal Defect Distal to the Mandibular Second Molar Following Surgical Extraction of the Third Molar
This study investigates whether the intraoperative application of a specialized regenerative gel (Emdogain®) can improve the periodontal health of the mandibular second molar by preventing or reducing the formation of tissue defects after the surgical removal of an adjacent impacted lower wisdom tooth.
Surgical extraction of a lower wisdom tooth frequently leaves a deep pocket or a permanent hard and/or soft tissue defect on the back side of the neighboring second molar. This defect compromise the surrounding tissues and predispose the healthy second molar to future complications like root caries, dentin hypersensitivity, or localized gum disease. While most existing treatments address these defects after they have formed, this trial evaluates a site-specific preventive approach during the extraction process itself.
Read more
The study will involve 70 systemically healthy adults (ages 18-45) requiring surgical removal of a horizontally or mesially oriented impacted lower third molar. Participants will be randomized into two equal groups:
The Test Group: Will receive root conditioning with PrefGel and a single application of Emdogain® gel directly to the root surface and socket immediately after tooth removal.
The Control Group: Will undergo identical surgery but will follow a natural, spontaneous healing process without the application of any biomaterials.
The main objective is to measure changes in Clinical Attachment Level (CAL) at the distal aspects of the second molar using stable vertical anatomical reference points over a 6-month period. The trial will also monitor secondary healing parameters, including probing pocket depths, gum recession, radiographic bone level changes using standardized jigs, postoperative pain, swelling, and early tissue healing dynamics.
Read the detailed description
The primary objective of this two-center, parallel-group, randomized clinical trial is to investigate whether the intraoperative application of Enamel Matrix Derivative (EMD) can improve the long-term periodontal health of the mandibular second molar by preventing or minimizing the formation of distal tissue defects following third molar surgery. While the regenerative properties of EMD are well-documented in periodontology, the novelty of this study lies in its prophylactic, site-specific usage at the immediate time of extraction.
Methodology and Standardization
To maximize data reproducibility and minimize measurement errors, the study incorporates the following rigorous standardization protocols:
Anatomical Selection: To control for surgical site variables and baseline defect morphology, inclusion is strictly limited to patients presenting with horizontally or mesially oriented impacted mandibular third molars.
Clinical Measurement Protocol: Clinical parameters are recorded at seven distinct sites around the mandibular second molar: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual, and mid-distal. Because the adjacent third molar, the surrounding soft tissue, and limited clinical visibility obscure the distal cementoenamel junction (CEJ) preoperatively, stable and reproducible vertical anatomical landmarks are utilized as reference points for all measurements adjacent to the extraction defect. The disto-buccal site is measured from the distal-buccal cusp tip; the disto-lingual site is measured from the distal-lingual cusp tip; and the mid-distal site is measured from the permanent occlusal (masticatory) surface of the second molar. The remaining four sites (mesio-buccal, mid-buccal, mesio-lingual, and mid-lingual) will be measured from the standard CEJ landmark as usual.
Examiner Calibration: All clinical measurements are performed by a single investigator who undergoes intensive pre-study calibration sessions targeting an intra-examiner intraclass correlation coefficient (ICC) ≥0.85, with scheduled recalibration to prevent measurement drift over time.
Radiographic Calibration and Alignment: To eliminate radiographic distortion and magnification errors, a calibration sphere (metal ball) with a fixed, known diameter of 5 mm is attached to the radiographic setup. Digital image analysis software utilizes the true dimensions of this 5 mm ball to calculate the precise, absolute bone level distances via a standard proportional scale (rule of three). All radiographs are captured using the long-cone paralleling technique, standardized via a customized film-positioning device and repeatable radiographic jigs to ensure identical alignment across all time points.
Study Arms and Follow-up:
Seventy systemically healthy participants (ages 18-45) are randomized to either the Test Arm (debridement, root conditioning with PrefGel, and site-specific application of Emdogain® gel) or the Control Arm (identical surgical protocol allowing for spontaneous healing via a natural blood clot). Both groups receive standardized postoperative pharmacological and oral hygiene care. Early soft-tissue healing and patient-reported outcomes are monitored during the first week, while definitive soft- and hard-tissue periodontal remodeling is evaluated at 6 months postoperatively.
- Being tested
- Enamel Matrix Derivative (Emdogain®)
- Keywords
- Enamel Matrix Derivative, Emdogain, Third Molar Surgery, Periodontal Defect, Osseous Defect, Clinical Attachment Level, Probing Pocket Depth, Periodontal Regeneration, Mandibular Second Molar, Prophylactic Periodontal Treatment
- Medical subject headings
- Alveolar Bone Loss, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel Matrix Derivative (Emdogain®)Other
Also called Enamel Matrix Proteins, Amelogenin, Straumann Emdogain, EMD
Application of 24% EDTA root conditioning gel (PrefGel) followed by the application of porcine-derived enamel matrix proteins (Emdogain®) to the distal root surface of the mandibular second molar prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Emdogain | Experimental | Participants in this arm will undergo standardized surgical extraction of the impacted mandibular third molar. Following extraction and thorough debridement of the defect, the exposed distal root surface of the adjacent second molar will be conditioned with 24% EDTA (PrefGel). After rinsing, Enamel Matrix Derivative (Emdogain®) will be applied directly to the site prior to standard suturing and primary closure. Receives: Other: Enamel Matrix Derivative (Emdogain®) |
| Spontaneous Healing | No intervention | Participants in this arm will undergo the identical standardized surgical extraction of the impacted mandibular third molar and thorough debridement of the defect. No root conditioning agents or regenerative biomaterials will be applied. The extraction socket and distal defect will be allowed to heal spontaneously via natural blood clot formation prior to standard suturing and primary closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) is a measurement of periodontal health indicating the position of the soft tissue attachment on the tooth root, measured in millimeters (mm) using a calibrated periodontal probe. It will be recorded at seven distinct sites on the mandibular second molar. For the distal sites directly adjacent to the extraction socket, fixed coronal reference points will be used to calculate relative CAL, as the cementoenamel junction (CEJ) is often compromised by the impaction.
For the remaining four sites on the second molar, the standard CEJ will be utilized as the fixed anatomical reference point.
A reduction in the distance from these reference points to the base of the periodontal pocket over time indicates a clinical gain of tissue attachment and successful healing.
Measured: Baseline (immediately prior to surgery) and 6 months post-surgery
Secondary outcomes (10)
Change in Radiographic Alveolar Bone Level
The vertical distance from the CEJ to the alveolar bone crest at the distal aspect of the mandibular second molar. Measurements will be conducted using standardized intraoral radiographs taken with the parallel cone technique and an individualized occlusal jig to ensure precise spatial reproducibility. The images will be calibrated using radiopaque spheres to account for magnification and will be evaluated by three independent, masked observers.
Measured: Baseline (immediate post-operative) and 6 months post-surgery
Change in Probing Pocket Depth (PPD)
Distance from the free gingival margin to the base of the periodontal pocket, measured in millimeters (mm) using a calibrated periodontal probe at the seven designated sites around the mandibular second molar (as defined in the primary outcome).
Measured: Baseline (immediately prior to surgery) and 6 months post-surgery
Change in Gingival Recession (REC)
Distance from the cementoenamel junction (CEJ) or fixed coronal reference point to the free gingival margin, measured in millimeters (mm) using a calibrated periodontal probe at the seven designated sites around the mandibular second molar.
Measured: Baseline and 6 months post-surgery
Change in Bleeding on Probing (BOP)
A dichotomous index (yes/no) assessing the presence or absence of bleeding after periodontal probing at the six sites around the mandibular second molar. It acts as a clinical indicator of localized tissue inflammation.
Measured: Baseline and 6 months post-surgery
Change in Plaque Index (PI)
Assessment of the presence or absence of supragingival dental plaque on the surfaces of the mandibular second molar, recorded to monitor the patient's oral hygiene compliance throughout the healing phase.
Measured: Baseline and 6 months post-surgery
Postoperative Facial Oedema
Assessment of postoperative extraoral swelling. This is quantified by measuring the distances between specific anatomical facial landmarks using a flexible measuring tape.
Measured: Baseline (pre-operative) and 7 days post-surgery
Postoperative Trismus (Maximum Interincisal Opening)
Measurement of maximum mouth opening capability to assess postoperative trismus. It is recorded as the maximum vertical distance in millimeters (mm) between the incisal edges of the maxillary and mandibular central incisors.
Measured: Baseline (pre-operative) and 7 days post-surgery
Postoperative Pain
Patient-reported postoperative pain intensity evaluated daily using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Additionally, the total number of analgesic tablets consumed by the patient will be recorded via a patient diary.
Measured: Daily for the first 7 days post-surgery
Oral Health-Related Quality of Life (OHIP-14)
Patient-reported outcome assessing the impact of the surgery on daily life using the validated 14-item Oral Health Impact Profile (OHIP-14) questionnaire. Total scores range from 0 to 56, with higher scores indicating a greater negative impact on the patient's quality of life.
Measured: Baseline (pre-operative), 7 days post-surgery and 6 months post-surgery
Change in Sleep Quality
Assessment of postoperative sleep quality and disturbances using the validated Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8a (PROMIS-SD SF 8a). This instrument specifically evaluates sleep quality over a 7-day recall period. It consists of 8 items, yielding a total score ranging from 8 to 40. Higher scores indicate greater sleep disturbance and a worse postoperative sleep experience.
Measured: Baseline (pre-operative) and 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start9 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, randomized controlled clinical trial. Eligible participants scheduled for the surgical extraction of an impacted mandibular third molar are randomly assigned in a 1:1 allocation ratio to either the Test Arm (extraction followed by root conditioning with PrefGel and the application of Emdogain®) or the Control Arm (extraction allowing for spontaneous natural blood clot healing). Both groups are followed simultaneously in parallel pathways and are evaluated at identical postoperative intervals for a total duration of 6 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Ioulianos Apessos, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718932
- Sponsor's protocol ID
- 316/18.12.2025.
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Enamel Matrix Derivative in Reducing the Periodontal Defect Distal to the Mandibular Second Molar Following Surgical Extraction of the Third Molar
- ClinicalTrials.gov ID
- NCT07718932
- Acronym / sponsor ID
- 316/18.12.2025.
- Keywords
- Enamel Matrix Derivative, Emdogain, Third Molar Surgery, Periodontal Defect, Osseous Defect, Clinical Attachment Level, Probing Pocket Depth, Periodontal Regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the intraoperative application of a specialized regenerative gel (Emdogain®) can improve the periodontal health of the mandibular second molar by preventing or reducing the formation of tissue defects after the surgical removal of an adjacent impacted lower wisdom tooth.
Surgical extraction of a lower wisdom tooth frequently leaves a deep pocket or a permanent hard and/or soft tissue defect on the back side of the neighboring second molar. This defect compromise the surrounding tissues and predispose the healthy second molar to future complications like root caries, dentin hypersensitivity, or localized gum disease. While most existing treatments address these defects after they have formed, this trial evaluates a site-specific preventive approach during the extraction process itself.
The study will involve 70 systemically healthy adults (ages 18-45) requiring surgical removal of a horizontally or mesially oriented impacted lower third molar. Participants will be randomized into two equal groups:
The Test Group: Will receive root conditioning with PrefGel and a single application of Emdogain® gel directly to the root surface and socket immediately after tooth removal.
The Control Group: Will undergo identical surgery but will follow a natural, spontaneous healing process without the application of any biomaterials.
The main objective is to measure changes in Clinical Attachment Level (CAL) at the distal aspects of the second molar using stable vertical anatomical reference points over a 6-month period. The trial will also monitor secondary healing parameters, including probing pocket depths, gum recession, radiographic bone level changes using standardized jigs, postoperative pain, swelling, and early tissue healing dynamics.
Detailed description
The primary objective of this two-center, parallel-group, randomized clinical trial is to investigate whether the intraoperative application of Enamel Matrix Derivative (EMD) can improve the long-term periodontal health of the mandibular second molar by preventing or minimizing the formation of distal tissue defects following third molar surgery. While the regenerative properties of EMD are well-documented in periodontology, the novelty of this study lies in its prophylactic, site-specific usage at the immediate time of extraction.
Methodology and Standardization
To maximize data reproducibility and minimize measurement errors, the study incorporates the following rigorous standardization protocols:
Anatomical Selection: To control for surgical site variables and baseline defect morphology, inclusion is strictly limited to patients presenting with horizontally or mesially oriented impacted mandibular third molars.
Clinical Measurement Protocol: Clinical parameters are recorded at seven distinct sites around the mandibular second molar: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual, and mid-distal. Because the adjacent third molar, the surrounding soft tissue, and limited clinical visibility obscure the distal cementoenamel junction (CEJ) preoperatively, stable and reproducible vertical anatomical landmarks are utilized as reference points for all measurements adjacent to the extraction defect. The disto-buccal site is measured from the distal-buccal cusp tip; the disto-lingual site is measured from the distal-lingual cusp tip; and the mid-distal site is measured from the permanent occlusal (masticatory) surface of the second molar. The remaining four sites (mesio-buccal, mid-buccal, mesio-lingual, and mid-lingual) will be measured from the standard CEJ landmark as usual.
Examiner Calibration: All clinical measurements are performed by a single investigator who undergoes intensive pre-study calibration sessions targeting an intra-examiner intraclass correlation coefficient (ICC) ≥0.85, with scheduled recalibration to prevent measurement drift over time.
Radiographic Calibration and Alignment: To eliminate radiographic distortion and magnification errors, a calibration sphere (metal ball) with a fixed, known diameter of 5 mm is attached to the radiographic setup. Digital image analysis software utilizes the true dimensions of this 5 mm ball to calculate the precise, absolute bone level distances via a standard proportional scale (rule of three). All radiographs are captured using the long-cone paralleling technique, standardized via a customized film-positioning device and repeatable radiographic jigs to ensure identical alignment across all time points.
Study Arms and Follow-up:
Seventy systemically healthy participants (ages 18-45) are randomized to either the Test Arm (debridement, root conditioning with PrefGel, and site-specific application of Emdogain® gel) or the Control Arm (identical surgical protocol allowing for spontaneous healing via a natural blood clot). Both groups receive standardized postoperative pharmacological and oral hygiene care. Early soft-tissue healing and patient-reported outcomes are monitored during the first week, while definitive soft- and hard-tissue periodontal remodeling is evaluated at 6 months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized controlled clinical trial. Eligible participants scheduled for the surgical extraction of an impacted mandibular third molar are randomly assigned in a 1:1 allocation ratio to either the Test Arm (extraction followed by root conditioning with PrefGel and the application of Emdogain®) or the Control Arm (extraction allowing for spontaneous natural blood clot healing). Both groups are followed simultaneously in parallel pathways and are evaluated at identical postoperative intervals for a total duration of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Emdogain | Experimental | Other: Enamel Matrix Derivative (Emdogain®)Participants in this arm will undergo standardized surgical extraction of the impacted mandibular third molar. Following extraction and thorough debridement of the defect, the exposed distal root surface of the adjacent second molar will be conditioned with 24% EDTA (PrefGel). After rinsing, Enamel Matrix Derivative (Emdogain®) will be applied directly to the site prior to standard suturing and primary closure. |
| Spontaneous Healing | No intervention | –Participants in this arm will undergo the identical standardized surgical extraction of the impacted mandibular third molar and thorough debridement of the defect. No root conditioning agents or regenerative biomaterials will be applied. The extraction socket and distal defect will be allowed to heal spontaneously via natural blood clot formation prior to standard suturing and primary closure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult patients aged 18 to 35 years old (ASA I or II).
- Presence of an asymptomatic, partially or fully impacted mandibular third molar requiring surgical extraction.
- The third molar impaction must be mesioangular or horizontal, with its crown in direct physical contact with the adjacent second molar, as assessed by a preoperative panoramic radiograph.
- The adjacent mandibular second molar must be vital, fully erupted, and structurally sound (free of extensive dental caries or prosthetic crowns).
- Patients must demonstrate an adequate level of overall oral hygiene and gingival health (e.g., Full-Mouth Plaque Index < 20% and Full-Mouth Bleeding Score < 20% following initial prophylaxis and oral hygiene instructions).
Key exclusion criteria (8 listed)
- Presence of systemic diseases or conditions that could compromise wound healing or periodontal health (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
- Current or recent use of medications known to affect bone metabolism or wound healing (e.g., bisphosphonates, long-term systemic corticosteroids, immunosuppressants).
- History of heavy smoking (e.g., >10 cigarettes per day) or use of smokeless tobacco products.
- Pregnant or lactating females.
- Diagnosis of periodontitis (Stage II, III, or IV) affecting the remaining dentition, excluding the localized defect associated with the impacted third molar.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enamel Matrix Derivative (Emdogain®)Also: Enamel Matrix Proteins, Amelogenin, Straumann Emdogain, EMDApplication of 24% EDTA root conditioning gel (PrefGel) followed by the application of porcine-derived enamel matrix proteins (Emdogain®) to the distal root surface of the mandibular second molar prior to wound closure. | Other | Emdogain |
Primary outcome
Change in Clinical Attachment Level (CAL)
Time frame: Baseline (immediately prior to surgery) and 6 months post-surgery
Clinical Attachment Level (CAL) is a measurement of periodontal health indicating the position of the soft tissue attachment on the tooth root, measured in millimeters (mm) using a calibrated periodontal probe. It will be recorded at seven distinct sites on the mandibular second molar. For the distal sites directly adjacent to the extraction socket, fixed coronal reference points will be used to calculate relative CAL, as the cementoenamel junction (CEJ) is often compromised by the impaction. For the remaining four sites on the second molar, the standard CEJ will be utilized as the fixed anatomical reference point. A reduction in the distance from these reference points to the base of the periodontal pocket over time indicates a clinical gain of tissue attachment and successful healing.
10 secondary outcomes
Change in Radiographic Alveolar Bone Level
Time frame: Baseline (immediate post-operative) and 6 months post-surgery
Change in Probing Pocket Depth (PPD)
Time frame: Baseline (immediately prior to surgery) and 6 months post-surgery
Change in Gingival Recession (REC)
Time frame: Baseline and 6 months post-surgery
Change in Bleeding on Probing (BOP)
Time frame: Baseline and 6 months post-surgery
Change in Plaque Index (PI)
Time frame: Baseline and 6 months post-surgery
Postoperative Facial Oedema
Time frame: Baseline (pre-operative) and 7 days post-surgery
Postoperative Trismus (Maximum Interincisal Opening)
Time frame: Baseline (pre-operative) and 7 days post-surgery
Postoperative Pain
Time frame: Daily for the first 7 days post-surgery
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline (pre-operative), 7 days post-surgery and 6 months post-surgery
Change in Sleep Quality
Time frame: Baseline (pre-operative) and 7 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel Matrix Derivative (Emdogain®) in people with Alveolar Bone Loss and Periodontal Pocket, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioulianos Dimitrios Apessos, DDS, MD, MSc (+306937098861, idapessos@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Level (CAL) (time frame: Baseline (immediately prior to surgery) and 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.