Molar, ThirdNCT05722509
Evaluation of a New Technique for Periodontal Pocket Reduction in the Extraction of Wisdom Teeth
A study testing "Distal Flap Reduction" Group and "Only Exodontia" Group in people with Molar, Third and Periodontal Pocket, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
On many occasions, clinicians find situations in which they have to perform extractions of erupted or semi-erupted third molars or wisdom teeth where there are pre-existing periodontal pockets distal to the second molars, caused by a bone defect due to periodontal disease or due to malposition of the wisdom tooth… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Molar, Third, Periodontal Pocket
- What is being tested?
- "Distal Flap Reduction" Group and "Only Exodontia" Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who require third molar extraction and who have periodontal pockets distal to the adjacent second molars.
- In the second molars there should be enough keratinized gingiva to allow for a buccal and/or lingual-palatal buckle (minimum residual band of 2 mm).
- Patients of either sex.
- Patients over 18 years old.
- Healthy patients or in a controlled periodontal situation (previously treated with basic periodontal therapy with scaling and root planing with probing depths of less than 4 mm and bleeding index at probing <25%).
- In the case of pharmacologically treated patients, they should be properly controlled and request prior consultation to evaluate pharmacological treatments that may lead to hematological alterations.
Who cannot join
- Patients with uncontrolled pathologies or systemic conditions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Universitaria Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
About this study
Official title: Evaluation of a Periodontal Pocket Reduction Technique Applied to Exodontia of Erupted or Semi-erupted Wisdom Teeth
On many occasions, clinicians find situations in which they have to perform extractions of erupted or semi-erupted third molars or wisdom teeth where there are pre-existing periodontal pockets distal to the second molars, caused by a bone defect due to periodontal disease or due to malposition of the wisdom tooth concerning the second molar.
After the extraction of an erupted or semi-included third molar, and as a consequence of factors related to dental malposition or bone defects caused by periodontal disease, periodontal pockets can arise on the distal surface of the second molar.
Read more
When such exodontia is performed conventionally without raising a flap or applying any suturing technique in which there is a primary closure of the wound, there is a greater probability of persistence of periodontal pockets; and, in the worst case, they may increase after healing and closure of the alveolus. The consequence would be the formation of an enlarged and unattached tissue on the distal aspect of the second molar.
The fact that periodontal pockets persist acts as an unfavorable prognostic factor. The predictive power of subsequent periodontal destruction increases since these are areas where bacteria will continue to accumulate (etiological factor of periodontal disease), and where the patient will not be able to access for their elimination and control. This is why a surgical technique called "distal wedge" has been proposed to eliminate these pockets.
To avoid this second surgical procedure, we propose a procedure immediately after the conventional exodontic technique; where after performing a small gingivectomy and lifting a mucoperiosteal flap based on periodontal respective surgery concepts, primary closure of the alveolus and repositioning of the flaps at the level of the bone crest is achieved, eliminating these pre-existing pockets. This requires the existence of sufficient keratinized gingiva to maintain a band of at least 2 mm of keratinized tissue after the gingivectomy, thus ensuring a correct adherent tissue that provides sealing and proper maintenance of the periodontal tissues around the tooth. The proposed technique has been termed a "distal reduction flap" (DRF).
Read the detailed description
The study population will be the patients of the University Clinic of the Rey Juan Carlos University of Madrid.
A non-probabilistic selection method will be used in the Master's Degree in Periodontology and Osseointegration and the Integrated Adult Clinical Dentistry course, for those patients who meet the inclusion criteria for the study.
Patients will be assigned to the experimental and control groups by probabilistic methods using a table of random numbers.
Variables:
Independent Variable: Surgical technique. In the experimental group, the Distal Reduction Flap (DRF) technique and primary wound closure will be used. In the control group, the conventional exodontic technique and secondary wound closure will be used.
Dependent variables. The reduction of probing depth at 6 weeks (RPS6) and 18 weeks (RPS18) will be evaluated. Modifying variables: The contribution of the following socioeconomic variables will be assessed:
Sex (male, female) Age (years) Systemic Diseases (Yes, No) Medication (Specify which) Tobacco (Yes, No) Mechanical Dental Plaque Control (Manual Brushing, Electric Brushing, or both) Chemical Dental Plaque Control (Yes, No)
The sequence of work:
T.0: A first consultation "Interview" will be carried out in which the nature of the study will be explained to the patient. A check will be made to see if the patient meets the inclusion criteria to take part in the study.
Periodontal probing with a Hu-Friedy® CP15 probe with 1 mm markings with a range of 0 to 15 mm. There will be a periodontal pocket distal to the second molars (probing depth equal to or greater than 4 mm).
- The patient must be periodontally stable: Periodontal probing equal to or less than 4 mm and with bleeding on probing (BOP) index less than 25%.
- Measure the amount of keratinized gingiva on vestibular and lingual/palatal second molars with a Hu-Friedy® CP15 periodontal probe, measuring the distance between the gingival margin and the amelo-cement line. There will be a minimum of 3 mm, to make a 1 mm buckle and keep at least a 2 mm band remaining.
- Photographic records with Nikon®D5200 digital SLR camera body, with Nikon® compatible Sigma® 50 mm macro lens, Meke® ring flash, side mirror, and lip retractors.
T.1: On the day of surgery the working procedure will consist of:
- Anesthetic technique will be performed with infiltrative injection if it is in the upper jaw for blockade of the Posterior Alveolar Nerve and Palatine Nerve Major and Minor, and if it is in the lower jaw, regional injection will be performed for blockade of the Inferior Dental Nerve, Lingual Nerve and infiltrative for blockade of the Buccal Nerve. With Articaine 4% with epinephrine at 1:100.000. Ultracain ® (Normon® Laboratories, Madrid, Spain).
- The intervention will be performed according to the assigned randomization.
T.2: A review will be performed after 14 days and a photographic record will be taken, together with suture removal in the case of the study group. Post-operative discomfort perceived by the patient during the 3 days following the intervention will be recorded using V.A.E.
T.3: A review will be carried out 6 weeks after the intervention, where in addition to a photographic record, periodontal probing will be repeated with a Hu-Friedy® CP15 probe in the distal part of the 2nd molar. The reduction, persistence, or increase of the pre-existing periodontal pocket will be assessed.
T.4: A check-up will be performed at 12 weeks (18 weeks after the intervention). A new periodontal probing with a Hu-Friedy® CP15 probe in the distal part of the 2nd molar and a new photographic record will be taken.
- Conditions
- Molar, Third, Periodontal Pocket
- Being tested
- "Distal Flap Reduction" Group, "Only Exodontia" Group
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Distal Flap Reduction" GroupProcedure or surgery
A surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed.
"Only Exodontia" GroupProcedure or surgery
Third molar exodontia without associated surgery.
| Study group | Role | What they receive |
|---|---|---|
| "Distal Reduction Flap" Group | Experimental | A surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed. Receives: Procedure: "Distal Flap Reduction" Group |
| "Only Exodontia" Group | Active comparator | Exodontia of the 3rd molar will be performed following the different steps in the simple exodontic technique without performing any other surgical procedure. Receives: Procedure: "Only Exodontia" Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
changes in probing depth
Measured: 6 and 18 weeks
Secondary outcomes (1)
Post-operative pain
A Visual Analog Scale (VAS) will be made to record the patient's assessment of the discomfort. The values of the scale will range from 1 to 10, with 1 being the score with the least pain and 10 being the score with the most postoperative pain.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start12 Sep 2022
- Primary completion31 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Molar, ThirdStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosario María Ramírez Puerta, Universidad Rey Juan Carlos
- Investigators
- Antonio Francisco López Sánchez, MD, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722509
- Sponsor's protocol ID
- DRF1
- Status last verified
- May 2024
- First submitted
- 20 Jan 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robinson RE. The distal wedge operation. Periodontics. 1966 Sep-Oct;4(5):256-64. No abstract available.
PubMed 5223126Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.
PubMed 18549447Lindhe J, Socransky SS, Nyman S, Haffajee A, Westfelt E. "Critical probing depths" in periodontal therapy. J Clin Periodontol. 1982 Jul;9(4):323-36. doi: 10.1111/j.1600-051x.1982.tb02099.x.
PubMed 6764782Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
PubMed 4507712Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.
PubMed 330574Stetler KJ, Bissada NF. Significance of the width of keratinized gingiva on the periodontal status of teeth with submarginal restorations. J Periodontol. 1987 Oct;58(10):696-700. doi: 10.1902/jop.1987.58.10.696.
PubMed 2444693Claffey N, Nylund K, Kiger R, Garrett S, Egelberg J. Diagnostic predictability of scores of plaque, bleeding, suppuration and probing depth for probing attachment loss. 3 1/2 years of observation following initial periodontal therapy. J Clin Periodontol. 1990 Feb;17(2):108-14. doi: 10.1111/j.1600-051x.1990.tb01071.x.
PubMed 2406292Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.
PubMed 23574468
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Periodontal Pocket Reduction Technique Applied to Exodontia of Erupted or Semi-erupted Wisdom Teeth
- ClinicalTrials.gov ID
- NCT05722509
- Acronym / sponsor ID
- DRF1
- Conditions
- Molar, Third, Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Feb 2023 (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.
On many occasions, clinicians find situations in which they have to perform extractions of erupted or semi-erupted third molars or wisdom teeth where there are pre-existing periodontal pockets distal to the second molars, caused by a bone defect due to periodontal disease or due to malposition of the wisdom tooth concerning the second molar.
After the extraction of an erupted or semi-included third molar, and as a consequence of factors related to dental malposition or bone defects caused by periodontal disease, periodontal pockets can arise on the distal surface of the second molar.
When such exodontia is performed conventionally without raising a flap or applying any suturing technique in which there is a primary closure of the wound, there is a greater probability of persistence of periodontal pockets; and, in the worst case, they may increase after healing and closure of the alveolus. The consequence would be the formation of an enlarged and unattached tissue on the distal aspect of the second molar.
The fact that periodontal pockets persist acts as an unfavorable prognostic factor. The predictive power of subsequent periodontal destruction increases since these are areas where bacteria will continue to accumulate (etiological factor of periodontal disease), and where the patient will not be able to access for their elimination and control. This is why a surgical technique called "distal wedge" has been proposed to eliminate these pockets.
To avoid this second surgical procedure, we propose a procedure immediately after the conventional exodontic technique; where after performing a small gingivectomy and lifting a mucoperiosteal flap based on periodontal respective surgery concepts, primary closure of the alveolus and repositioning of the flaps at the level of the bone crest is achieved, eliminating these pre-existing pockets. This requires the existence of sufficient keratinized gingiva to maintain a band of at least 2 mm of keratinized tissue after the gingivectomy, thus ensuring a correct adherent tissue that provides sealing and proper maintenance of the periodontal tissues around the tooth. The proposed technique has been termed a "distal reduction flap" (DRF).
Detailed description
The study population will be the patients of the University Clinic of the Rey Juan Carlos University of Madrid.
A non-probabilistic selection method will be used in the Master's Degree in Periodontology and Osseointegration and the Integrated Adult Clinical Dentistry course, for those patients who meet the inclusion criteria for the study.
Patients will be assigned to the experimental and control groups by probabilistic methods using a table of random numbers.
Variables:
Independent Variable: Surgical technique. In the experimental group, the Distal Reduction Flap (DRF) technique and primary wound closure will be used. In the control group, the conventional exodontic technique and secondary wound closure will be used.
Dependent variables. The reduction of probing depth at 6 weeks (RPS6) and 18 weeks (RPS18) will be evaluated. Modifying variables: The contribution of the following socioeconomic variables will be assessed:
Sex (male, female) Age (years) Systemic Diseases (Yes, No) Medication (Specify which) Tobacco (Yes, No) Mechanical Dental Plaque Control (Manual Brushing, Electric Brushing, or both) Chemical Dental Plaque Control (Yes, No)
The sequence of work:
T.0: A first consultation "Interview" will be carried out in which the nature of the study will be explained to the patient. A check will be made to see if the patient meets the inclusion criteria to take part in the study.
Periodontal probing with a Hu-Friedy® CP15 probe with 1 mm markings with a range of 0 to 15 mm. There will be a periodontal pocket distal to the second molars (probing depth equal to or greater than 4 mm).
- The patient must be periodontally stable: Periodontal probing equal to or less than 4 mm and with bleeding on probing (BOP) index less than 25%.
- Measure the amount of keratinized gingiva on vestibular and lingual/palatal second molars with a Hu-Friedy® CP15 periodontal probe, measuring the distance between the gingival margin and the amelo-cement line. There will be a minimum of 3 mm, to make a 1 mm buckle and keep at least a 2 mm band remaining.
- Photographic records with Nikon®D5200 digital SLR camera body, with Nikon® compatible Sigma® 50 mm macro lens, Meke® ring flash, side mirror, and lip retractors.
T.1: On the day of surgery the working procedure will consist of:
- Anesthetic technique will be performed with infiltrative injection if it is in the upper jaw for blockade of the Posterior Alveolar Nerve and Palatine Nerve Major and Minor, and if it is in the lower jaw, regional injection will be performed for blockade of the Inferior Dental Nerve, Lingual Nerve and infiltrative for blockade of the Buccal Nerve. With Articaine 4% with epinephrine at 1:100.000. Ultracain ® (Normon® Laboratories, Madrid, Spain).
- The intervention will be performed according to the assigned randomization.
T.2: A review will be performed after 14 days and a photographic record will be taken, together with suture removal in the case of the study group. Post-operative discomfort perceived by the patient during the 3 days following the intervention will be recorded using V.A.E.
T.3: A review will be carried out 6 weeks after the intervention, where in addition to a photographic record, periodontal probing will be repeated with a Hu-Friedy® CP15 probe in the distal part of the 2nd molar. The reduction, persistence, or increase of the pre-existing periodontal pocket will be assessed.
T.4: A check-up will be performed at 12 weeks (18 weeks after the intervention). A new periodontal probing with a Hu-Friedy® CP15 probe in the distal part of the 2nd molar and a new photographic record will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Distal Reduction Flap" Group | Experimental | Procedure: "Distal Flap Reduction" GroupA surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed. |
| "Only Exodontia" Group | Active comparator | Procedure: "Only Exodontia" GroupExodontia of the 3rd molar will be performed following the different steps in the simple exodontic technique without performing any other surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who require third molar extraction and who have periodontal pockets distal to the adjacent second molars.
- In the second molars there should be enough keratinized gingiva to allow for a buccal and/or lingual-palatal buckle (minimum residual band of 2 mm).
- Patients of either sex.
- Patients over 18 years old.
- Healthy patients or in a controlled periodontal situation (previously treated with basic periodontal therapy with scaling and root planing with probing depths of less than 4 mm and bleeding index at probing <25%).
Key exclusion criteria (1 listed)
- Patients with uncontrolled pathologies or systemic conditions.
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 |
|---|---|---|
| "Distal Flap Reduction" GroupA surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed. | Procedure or surgery | "Distal Reduction Flap" Group |
| "Only Exodontia" GroupThird molar exodontia without associated surgery. | Procedure or surgery | "Only Exodontia" Group |
Primary outcome
Probing depth
Time frame: 6 and 18 weeks
changes in probing depth
1 secondary outcome
Post-operative pain
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 5223126Robinson RE. The distal wedge operation. Periodontics. 1966 Sep-Oct;4(5):256-64. No abstract available.
- Background: PubMed 18549447Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.
- Background: PubMed 6764782Lindhe J, Socransky SS, Nyman S, Haffajee A, Westfelt E. "Critical probing depths" in periodontal therapy. J Clin Periodontol. 1982 Jul;9(4):323-36. doi: 10.1111/j.1600-051x.1982.tb02099.x.
- Background: PubMed 4507712Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
- Background: PubMed 330574Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.
- Background: PubMed 2444693Stetler KJ, Bissada NF. Significance of the width of keratinized gingiva on the periodontal status of teeth with submarginal restorations. J Periodontol. 1987 Oct;58(10):696-700. doi: 10.1902/jop.1987.58.10.696.
- Background: PubMed 2406292Claffey N, Nylund K, Kiger R, Garrett S, Egelberg J. Diagnostic predictability of scores of plaque, bleeding, suppuration and probing depth for probing attachment loss. 3 1/2 years of observation following initial periodontal therapy. J Clin Periodontol. 1990 Feb;17(2):108-14. doi: 10.1111/j.1600-051x.1990.tb01071.x.
- Background: PubMed 23574468Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antonio Francisco López Sánchez, MD, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Distal Flap Reduction" Group and "Only Exodontia" Group in people with Molar, Third and Periodontal Pocket, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 6 and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722509, which also lists 8 linked publications.
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 5 May 2026.