Soft Tissue HealingNCT04353999
The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation
A study testing Socket sealing by diode laser photocoagulation and socket sealing with dense polytetrafluroethylene membrane in people with Soft Tissue Healing, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Healing
- What is being tested?
- Socket sealing by diode laser photocoagulation and socket sealing with dense polytetrafluroethylene membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Dec 2019
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
- Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
- Adult patients (aged 18-50 years).
- A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.
Who cannot join
- The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
- The presence of any local factor that may interfere with extraction as tooth ankylosis.
- Smoking.
- The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
- Subjects who had undergone radiation therapy.
- Patients who had been subjected to or who were under bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Diode Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation in the Esthetic Zone.
The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.
Read the detailed description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket
All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.
- Conditions
- Soft Tissue Healing
- Being tested
- Socket sealing by diode laser photocoagulation, socket sealing with dense polytetrafluroethylene membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket sealing by diode laser photocoagulationProcedure or surgery
tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes
socket sealing with dense polytetrafluroethylene membraneProcedure or surgery
tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket
| Study group | Role | What they receive |
|---|---|---|
| 980 nm diode laser photocoagulation | Experimental | 980 nm diode laser was used to coagulate the blood over the bone graft particles and achieve a socket seal after socket grafting Receives: Procedure: Socket sealing by diode laser photocoagulation |
| Dense polytetrafluroethylene membrane | Active comparator | dPTFE membrane was used to seal the socket after grafting Receives: Procedure: socket sealing with dense polytetrafluroethylene membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing (the changes in the soft tissue color throughout the first month)
clinical examination and scoring according to Landry healing index. A score of 1 to 5 was given to the surgical site indicating the improvement of the nature of the soft tissue . A score of 1 meaning the least healing and 5 being excellent healing.
Measured: at 2nd, 3rd and 4th week
Secondary outcomes (3)
soft tissue thickness in millimeters.
The thickness of the soft tissue in the center of the socket was measured at the baseline and after 4 months on the cone beam computed tomoghraph using the ruler tool to measure the thickness in millimeters.
Measured: 4 months
Bone width and height measured in millimeters
bone dimensions were measured on the baseline cone beam computed tomograph and after 4 months also on the recall cone beam computed tomograph.
Measured: 4 months
pain score on the visual analogue scale (VAS)
Pain was measured on the first , forth and seventh day postoperatively. The visual analogue scale comprises a scale graded from 1 to 100 to express the pain on a a ruler the the patient uses to point out the pain score visually with 0 meaning no pain and 100 meaning maximum pain.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Mar 2019
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue HealingStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Ahmed A kamal, BDs, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353999
- Sponsor's protocol ID
- ORG 0008839
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.
Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
PubMed 6950834Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. doi: 10.1111/j.1834-7819.1969.tb06001.x. No abstract available.
PubMed 5259350Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diode Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation in the Esthetic Zone.
- ClinicalTrials.gov ID
- NCT04353999
- Acronym / sponsor ID
- ORG 0008839
- Conditions
- Soft Tissue Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Apr 2020 (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.
The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.
Detailed description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket
All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 980 nm diode laser photocoagulation | Experimental | Procedure: Socket sealing by diode laser photocoagulation980 nm diode laser was used to coagulate the blood over the bone graft particles and achieve a socket seal after socket grafting |
| Dense polytetrafluroethylene membrane | Active comparator | Procedure: socket sealing with dense polytetrafluroethylene membranedPTFE membrane was used to seal the socket after grafting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
- Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
- Adult patients (aged 18-50 years).
- A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.
Key exclusion criteria (6 listed)
- The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
- The presence of any local factor that may interfere with extraction as tooth ankylosis.
- Smoking.
- The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
- Subjects who had undergone radiation therapy.
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 |
|---|---|---|
| Socket sealing by diode laser photocoagulationtooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes | Procedure or surgery | 980 nm diode laser photocoagulation |
| socket sealing with dense polytetrafluroethylene membranetooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket | Procedure or surgery | Dense polytetrafluroethylene membrane |
Primary outcome
Soft tissue healing (the changes in the soft tissue color throughout the first month)
Time frame: at 2nd, 3rd and 4th week
clinical examination and scoring according to Landry healing index. A score of 1 to 5 was given to the surgical site indicating the improvement of the nature of the soft tissue . A score of 1 meaning the least healing and 5 being excellent healing.
3 secondary outcomes
soft tissue thickness in millimeters.
Time frame: 4 months
Bone width and height measured in millimeters
Time frame: 4 months
pain score on the visual analogue scale (VAS)
Time frame: 1 week
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 21 Apr 2020.
- BackgroundLandry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.
- Background: PubMed 6950834Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
- Background: PubMed 5259350Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. doi: 10.1111/j.1834-7819.1969.tb06001.x. No abstract available.
- Results publication: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- 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.
Ahmed A kamal, BDs principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket sealing by diode laser photocoagulation and socket sealing with dense polytetrafluroethylene membrane in people with Soft Tissue Healing, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 4 inclusion and 6 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 21 Apr 2020. 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 Egypt. 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?
Soft tissue healing (the changes in the soft tissue color throughout the first month) (time frame: at 2nd, 3rd and 4th week). 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 NCT04353999, which also lists 4 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 21 Apr 2020.